173
BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITY MINISTRY OF HEALTH, BRUNEI DARUSSALAM LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020) No Product Registration Number Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the end of the validity period as stated) Product Classification 1 BRU07100001P Augmentin Injection 1.2g Co-Amoxiclav 1000/200 - Amoxicillin 1g as sodium salt, clavulanic acid 200mg as potassium salt SmithKline Beecham PLC, Worthing, West Sussex, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025 POM 2 BRU07100002P Augmentin Injection 600mg Co-Amoxiclav 500/100 - Amoxicillin 500mg as sodium salt, clavulanic acid 100mg as potassium salt SmithKline Beecham PLC, Worthing, West Sussex, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025 POM 3 BRU08010001P Pharmaniaga Aciclovir Tablet 200mg Aciclovir 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 4 BRU08010003P Pharmaniaga Clarithromycin Tablet 250mg Clarithromycin 250mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 5 BRU08010004P Pharmaniaga Fluconazole 150mg Capsules Fluconazole 150mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 6 BRU08010005P Pharmaniaga Ciprofloxacin Tablet 500mg Ciprofloxacin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 7 BRU08020012P Pharmaniaga Cephalexin Capsule 500mg Cephalexin 500mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 8 BRU08020013P Pharmaniaga Metronidazole Tablet 200mg Metronidazole 200mg Pharmaniaga Manufacturing Berhad Malaysia G & H Trading Company 06 October 2020 till 05 October 2025 POM 9 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05 October 2025 POM 10 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05 October 2025 POM 11 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05 October 2025 POM 12 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia Hongkiat Trading & Company 06 October 2020 till 05 October 2025 POM 13 BRU08020020P Diprivan 10mg/ml (1%) Emulsion for Injection or Infusion (20ml Ampoule) Propofol 10mg/ml (1%) Corden Pharma S.P.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025 POM 14 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate); Clavulanic acid 125mg (as Potassium Clavulanate) SmithKline Beecham Plc, Worthing, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025 POM 15 BRU08030024P Augmentin Suspension 228mg/5ml Amoxycillin 200mg/5ml (as trihydrate); Clavulanic acid 28.5mg/5ml (as Potassium Clavulanate) Glaxo Wellcome Production ZI de la Peyenniere 53100 Mayenne France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025 POM BDMCA/RMP/1220 Page 1 of 173

BRUNEI DARUSSALAM MEDICINES CONTROL ... Documents/registered medicinal...POM 14 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate); Clavulanic acid 125mg (as Potassium

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Page 1: BRUNEI DARUSSALAM MEDICINES CONTROL ... Documents/registered medicinal...POM 14 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate); Clavulanic acid 125mg (as Potassium

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1 BRU07100001P Augmentin Injection 1.2g Co-Amoxiclav 1000/200 - Amoxicillin 1g as sodium salt, clavulanic acid 200mg as potassium salt

SmithKline Beecham PLC, Worthing, West Sussex, UK

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

2 BRU07100002P Augmentin Injection 600mg Co-Amoxiclav 500/100 - Amoxicillin 500mg as sodium salt, clavulanic acid 100mg as potassium salt

SmithKline Beecham PLC, Worthing, West Sussex, UK

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

3 BRU08010001P Pharmaniaga Aciclovir Tablet 200mg

Aciclovir 200mg Pharmaniaga Manufacturing Berhad Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

4 BRU08010003P Pharmaniaga Clarithromycin Tablet 250mg

Clarithromycin 250mg Pharmaniaga Manufacturing Berhad Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

5 BRU08010004P Pharmaniaga Fluconazole 150mg Capsules

Fluconazole 150mg Pharmaniaga Manufacturing Berhad Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

6 BRU08010005P Pharmaniaga Ciprofloxacin Tablet 500mg

Ciprofloxacin 500mg Pharmaniaga Manufacturing Berhad Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

7 BRU08020012P Pharmaniaga Cephalexin Capsule 500mg

Cephalexin 500mg Pharmaniaga Manufacturing Berhad Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

8 BRU08020013P Pharmaniaga Metronidazole Tablet 200mg

Metronidazole 200mg Pharmaniaga Manufacturing Berhad Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

9 BRU08020016P Anikef Sterile 750mg Cefuroxime 750mg Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

10 BRU08020017P Bicafar Sterile 1g Cefoperazone 1g Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

11 BRU08020018P Betamox Granules 125mg/5ml Amoxicillin 125mg/5ml Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

12 BRU08020019P Betamox Granules 250mg/5ml Amoxicillin 250mg/5ml Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

13 BRU08020020P Diprivan 10mg/ml (1%) Emulsion for Injection or Infusion (20ml Ampoule)

Propofol 10mg/ml (1%) Corden Pharma S.P.A, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

14 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate); Clavulanic acid 125mg (as Potassium Clavulanate)

SmithKline Beecham Plc, Worthing, UK

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

15 BRU08030024P Augmentin Suspension 228mg/5ml

Amoxycillin 200mg/5ml (as trihydrate); Clavulanic acid 28.5mg/5ml (as Potassium Clavulanate)

Glaxo Wellcome Production ZI de la Peyenniere 53100 Mayenne France

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 1 of 173

Page 2: BRUNEI DARUSSALAM MEDICINES CONTROL ... Documents/registered medicinal...POM 14 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate); Clavulanic acid 125mg (as Potassium

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

16 BRU08030025P Augmentin Suspension 457mg/5ml

Amoxycillin 400mg/5ml (as trihydrate); Clavulanic acid 57mg/5ml (as Potassium Clavulanate)

Glaxo Wellcome Production ZI de la Peyenniere 53100 Mayenne France

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

17 BRU08030027P Foban Cream Fusidic acid 2% Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

18 BRU08030030P Garasent 80mg Injection Gentamicin 40mg/ml (as Sulphate) Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 October 2020 till 05 October 2025

POM

19 BRU08030031P Retrovir 1% IV Infusion Zidovudine 1% Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

20 BRU08030034P Zinacef Injection 750mg Cefuroxime (as sodium) ACS Dobfar S.p.A., Italy. Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

21 BRU08030037P Zinnat Tablet 250mg Cefuroxime (as axetil) Glaxo Wellcome Operations, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

22 BRU08040040P Retrovir Oral Solution Zidovudine 50mg/5ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

23 BRU08040041P Zeffix Tablet Lamivudine 100mg GlaxoSmithKline Pharmaceuticals S.A., Poland

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

24 BRU08040042P Combivir Tablet Lamivudine 100mg, Zidovudine 300mg GlaxoSmithKline Pharmaceuticals S.A., Poland

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

25 BRU08040043P Zoraxin Suspension Aciclovir 200mg/5ml Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

26 BRU08040045P Apalin Solution for Injection Amikacin Sulphate 500mg Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 October 2020 till 05 October 2025

POM

27 BRU08040047P Bicafar Sterile 2g (vial) Cefoperazone (as Sodium) 2g Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

28 BRU08040049P Diflucan IV Infusion 2mg/ml (50ml)

Fluconazole 2mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

29 BRU08040050P Sulperazone IM/IV 1g Sulbactam (as Sodium) 500mg; Cefoperazone (as Sodium) 500mg

Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

30 BRU08040052P Becarin Cream 2% Miconazole Nitrate 2% Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

GSL

31 BRU08050053P Pharmaniaga Aciclovir Tablet 400mg

Aciclovir 400mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

32 BRU08050054P Pharmaniaga Cephalexin Capsule 250mg

Cephalexin (as Anhydrous) Cephalexin 250mg

Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

33 BRU08050060P Unocef Injection 500mg (Vial) Ceftriaxone (as Sodium) 500mg Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

34 BRU08050061P Unocef Injection 1000mg (Vial)

Ceftriaxone (as Sodium) 1000mg Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

35 BRU08050062P Garasent 280mg Injection (2ml Ampoule)

Gentamicin (as Sulphate BP) 280mg Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 2 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

36 BRU08050066P Beagenta Eye/ Ear Drops Gentamicin Sulphate equivalent to Gentamicin 0.3%w/w

Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

37 BRU08050068P Krisovin Tablet 500 Griseofulvin BP 500mg (micronised) Duopharma Manufacturing (Bangi) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

38 BRU08050070P Betacin Eye Ear Drop Neomycin Sulphate 0.5% w/v; Betamethasone Sodium Phosphate 0.1%w/v

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 October 2020 till 05 October 2025

POM

39 BRU08050071P Foban Ointment Sodium Fusidate BP 2% w/v Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

40 BRU08050072P Fobancort Cream Fusidic acid 2%w/w; Betamethasone Dipropionate 0.064%w/w equivalent to Betamethasone 0.05%w/w

Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

41 BRU08050073P Dezor Cream Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

GSL

42 BRU08050074P Dezor Shampoo Ketoconazole 2%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

GSL

43 BRU08060075P Genta-Dex Eye Drops Gentamicin 0.3% w/v; Dexamethsone Phosphate 0.1%w/v

Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

44 BRU08060077P Aecoras Ointment Econazole Nitrate 10mg; Triamcinolone Acetonide 1mg

Tai Guk Pharm Co. Ltd., South Korea

Hongkiat Trading & Company 06 October 2015 till 05 October 2020 (PL extended to 05 April 2021)

POM

45 BRU08060078P Beapen VK Granules 125mg Phenoxymethypenicillin 125mg/5ml Upha Pharmaceutical Mfg (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

46 BRU08060079P Enoxin Tablet 500mg Ciprofloxacin 500mg Duopharma Manufacturing (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

47 BRU08060081P Betagen Eye/ Ear Drops Gentamicin Sulphate equivalent to Gentamicin 0.3%; Betamethasone Sodium Phosphate 0.1%

Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

48 BRU08060083P Eryson Granules 200 Erythromycin ethylsuccinate equiv. to eryhtromycin 200mg/5ml

Upha Pharmaceutical Mfg (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2020 till 05 October 2025

POM

49 BRU08060084P Eryson Granules 400 Erythromycin ethylsuccinate equiv. to eryhtromycin 400mg/5ml

Upha Pharmaceutical Mfg (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

50 BRU08060085P Neo Cream 0.5% (w/w) Neomycin sulphate 0.5%w/w Duopharma Manufacturing (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

51 BRU08060086P Foban Hydro Cream Fusidic acid 2%; Hydrocortisone 1% Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

52 BRU08060087P Foban Hydro Ointment Sodium Fusidate 2%; Hydrocortisone 1%

Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

53 BRU08060088P Arava Tablet 10mg Leflunomide 10mg Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 3 of 173

Page 4: BRUNEI DARUSSALAM MEDICINES CONTROL ... Documents/registered medicinal...POM 14 BRU08030023P Augmentin Tablet 625mg Amoxycillin 500mg (as trihydrate); Clavulanic acid 125mg (as Potassium

BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

54 BRU08060089P Arava Tablet 20mg Leflunomide 20mg Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

55 BRU08070090P Zinnat Suspension 125mg/5ml Cefuroxime Axetil equivalent to Cefuroxime 125mg/5mL

Glaxo Wellcome Operations, Bernard Castle, United Kingdom.

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

56 BRU08070091P Metronol 0.5%w/v Injection Metronidazole 0.5% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 06 October 2020 till 05 October 2025

POM

57 BRU08070092P Eryson Tablet 250 Erythromycin Stearate BP equivalent to Eryhthromycin 250mg

Duopharma Manufacturing (Bangi) Sdn. Bhd.

K-Seri Pharma Sdn BHd 06 October 2020 till 05 October 2025

POM

58 BRU08070094P Ecocort Cream Econazole Nitrate 1% w/w; Triamcinolone Acetonide 0.1% w/w

Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

59 BRU08070095P Beprogent Ointment Betamethasone 0.05%; Gentamicin 0.1%

Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

60 BRU08070096P Betamox Capsule 250mg Amoxicillin Trihydrate equivalent to Amoxicillin 250mg

Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

61 BRU08070097P Aprovel Tablet 300mg Irbesartan 300mg Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

62 BRU08070099P Atacand Tablet 8mg Candesartan Cilexetil 8mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

63 BRU08070100P Atacand Tablet 16mg Candesartan Cilexetil 16mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

64 BRU08080104P Beavate Cream 0.1% Betamethasone -17- valerate equiv. to Betamethasone 0.1%

Upha Pharmaceutical Mfg (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

65 BRU08080106P Candazole Cream Clotrimazole 1.0% Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

GSL

66 BRU08080107P HOE Gentamicin Cream 0.1% w/w

Gentamicin (as Sulphate) 0.1% Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

67 BRU08080108P Beprogent Cream Betamethasone (as dipropionate) 0.05%, Gentamicin (as sulphate 0.1%)

Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

68 BRU08080109P Unasyn Tablet 375mg Sultamicillin (as tosilate) 375mg (Ampicillin 250mg & Sulbactam 125mg)

Pfizer Global Supply Japan Inc, Japan

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

69 BRU08080115P Vaxcel Cefuroxime 750mg Injection

Cefuroxime (as sodium) 750mg Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

70 BRU08080116P Vaxcel Ceftriaxone 1g Injection

Ceftriaxone (as sodium) 1g Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

71 BRU08080117P Axcel Fusi-Corte Cream Fusidic acid 2%, Betamethasone (as 17-valerate) 0.1%

Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 4 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

72 BRU08090118P Verorab Injection Inactivated rabies virus (Wistar strain RABIES PM/WI 38-1503-3M) produced on VERO cell line, inactivated and purifed

06 October 2020 till 05 October 2025

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

73 BRU08090119P Decocort Cream Miconazole Nitrate 2%w/w; Hydrocortisone 1% w/w

Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

P

74 BRU08090120P Fobancort Ointment Sodium Fusidate 2%w/w; Betamethasone 0.05%w/w (as Dipropionate 0.064%)

Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

75 BRU08090121P Candacort Cream Clotrimazole 1.0% w/w; Hydrocortisone 1.0%w/w

Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

P & POM

76 BRU08090124P Ciprobay® 200 Infusion Solution

Ciprofloxacin (as lactate) 200mg Bayer AG, Leverkeusen, Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

77 BRU08090125P Vaxcel Ceftazidime 2g Injection

Ceftazidime (as pentahydrate) 2g Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

78 BRU08090126P Axcel Fusidic Cream Fusidic acid 2% w/w Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

79 BRU08090127P Axcel Fusidic Ointment Sodium Fusidate 2%w/w Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

80 BRU08090128P Vaxcel Ceftazidime 1g Ceftazidime (as pentahydrate) 1g Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

81 BRU08090129P Axcel Miconazole Cream Miconazole Nitrate 2% w/w Kotra Pharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

GSL

82 BRU08090131P Beamoxy Capsule 500 Amoxicillin (as Trihydrate) 500mg Upha Pharmaceutical Mfg (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2020 till 05 October 2025

POM

83 BRU08100134P Decozol Cream Miconazole Nitrate 2%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

GSL

84 BRU08100135P Betamox Capsule 500mg Amoxicillin Trihydrate equivalent to Amoxicillin 500mg

Duopharma (M) Sdn Bhd Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

85 BRU08100137P Neo Deca Eye/Ear Drop Neomycin Sulphate 0.5%; Dexamethasone Sodium Phosphate 0.1% w/w

CCM Pharmaceutical Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

86 BRU08100139P Ciprobay® 500 Tablet Ciprofloxacin (as HCl monohydrate) 500mg

Bayer AG, Leverkeusen, Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

87 BRU08100142P Candazole Lotion Clotrimazole 1%w/w Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

GSL

88 BRU08100146NP Silfazine Cream Silver Sulfadiazine 1%w/w Sunward Pharmaceutical Sdn Bhd Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

P

89 BRU08110150P Avaxim 160U Suspension for Injection in a prefilled Syringe

Inactivated Hepatitis A Virus (GBM strain) 160u/0.5ml

Sanofi Pasteur, Lyon, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 5 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

90 BRU08110151P Aprovel 150mg Tablet Irbesartan 150mg Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

91 BRU08110152P Zovirax IV for Infusion 250mg Aciclovir 250mg GlaxoSmithKline Manufacturing SPA Italy

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

92 BRU08110153P Axcel Aciclovir Cream 5%w/w Aciclovir 5%w/w Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

P

93 BRU08110154P Axcel Eryhthromycin ES Tablet 400mg

Erythromycin (as ethyl succinate) 400mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

94 BRU08110155P Axcel Cephalexin-500 Capsule Cephalexin (as monohydrate) 500mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

95 BRU08110156P Axcel Eryhthromycin ES-200 Suspension

Erythromycin (as Ethylsuccinate) 200mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

96 BRU08110159P SW Miconazole Cream 2% w/w

Miconazole Nitrate 2.0%w/w Sunward Pharmaceutical Sdn Bhd Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

GSL

97 BRU08110162P Cordarone Tablet 200mg Amiodarone HCl 200mg Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

98 BRU08110163P CoAprovel 150/12.5mg Film-coated Tablet

Irbesartan 150mg, Hydrochlorothiazide 12.5mg

Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

99 BRU08120166P Ciprobay 250 Tablet Ciprofloxacin (as HCl monohydrate) 250mg

Bayer Pharma AG, Leverkusen, Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

100 BRU08120167P Axcel Cephalexin 250mg Caspule

Cephalexin (as Monohydrate) 250mg Kotra Pharma (M) Sdn Bhd Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

101 BRU08120168P Axcel Cephalexin 125mg Suspension

Cephalexin (as Monohydrate) 125mg Kotra Pharma (M) Sdn Bhd Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

102 BRU08120169P Oxacil Capsule 250 Cloxacillin (as Sodium) 250mg Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

103 BRU08120170P Hysone Cream 1% (w/w) Hydrocortisone acetate BP 1%w/w Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn BHd 06 October 2020 till 05 October 2025

P & POM

104 BRU08120173P Ventolin Respirator Solution Salbutamol (as sulphate) 0.5%w/v Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

105 BRU08120177P Beprosalic Lotion Betamethasone (as dipropionate) 0.05%, Salicylic acid 2.0%

Hoe Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

106 BRU08120180P Zithromax Film-coated Tablet 250mg

Azithromycin (as dihydrate) 250mg Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

107 BRU09010181P Unasyn 0.75mg IM/IV Ampicillin (as sodium) 500mg; Sulbactam (as sodium) 250mg

Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

108 BRU09010182P Unasyn 3.0g IM/IV Ampicillin (as sodium) 2000mg; Sulbactam (as sodium) 1000mg

Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

109 BRU09010183P Vaxcel Ceftriaxone-500mg Injection

Ceftriaxone (as sodium) 500mg Kotra Pharma (M) Sdn Bhd Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 6 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

110 BRU09010186P Plavix Tablet 75mg Clopidogrel (as Hydrogen Sulphate) 75mg

Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

111 BRU09010187P Symbicort Turbuhaler 160/4.5mcg dose

Budenoside 160mcg; Formoterol fumarate dihydrate 4.5mcg

AstraZeneca AB, Sodertalje, Sweden

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

112 BRU09010188P CoAprovel 300/12.5mg film-coated tablet

Irbesartan 300mg; Hydrochlorothiazide 12.5mg

Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

113 BRU09010191PS1 & BRU09010191PS2

Coversyl 8mg tablet Perindopril tert-butylamine 8mg Les Laboratoires Servier Industrie, France (S1) & Kotra Pharma (M) Sdn. Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

114 BRU09010194P Pulmicort turbuhaler 100mcg/dose

Budenoside 100mcg AstraZeneca AB, Sodertalje, Sweden

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

115 BRU09010195P Lantus for Optipen 100iu/ml Insulin glargine 100iu/ml Sanofi Aventis Deutschland, Germany

Medipharm Sdn Bhd 06 October 2015 till 05 October 2020

POM

116 BRU09020198P Adenocor Injection 6mg/2ml Adenosine 6mg/2ml Famar Health Care Services Madrid S.A.U., Madrid, Spain

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

117 BRU09020206P Bricanyl Turbuhaler 0.5mg/dose

Terbutaline Sulphate 0.5mg/dose AstraZeneca Dunkerque Production, Dunkerque Cedex 2, France

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

118 BRU09020207P Beprosalic Ointment Betamethasone (as Dipropionate 0.064%) 0.05% & Salicylic acid 3% w/w

HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading & Co 06 October 2020 till 05 October 2025

POM

119 BRU09020208P Beprogel Topical Solution Betamethasone (as Dipropionate 0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading & Co 06 October 2020 till 05 October 2025

POM

120 BRU09020209P Cloderm Scalp Application Clobetasol (as dipropionate) 0.05% w/v HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading & Co 06 October 2020 till 05 October 2025

POM

121 BRU09020210P Declovir Cream Acyclovir 5.0% w/w HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading & Co 06 October 2020 till 05 October 2025

P

122 BRU09020211P Lantus 100units/ml for Optiset Insulin Glargine (HOE 901) 100units/ml Sanofi-Aventis Deutschland GmbH, Germany

Medipharm Sdn Bhd 06 October 2015 till 05 October 2020

POM

123 BRU09020212P Glucobay 50 Tablet Acarbose 50mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

124 BRU09030213P 3TC Tablet 150mg Lamivudine 150mg GlaxoSmithKline Pharmaceuticals S.A., Poland

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

125 BRU09030214P 3TC Oral Solution 10mg/ml Lamivudine 10mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

126 BRU09030216P Cordarone Injection 150mg/3ml

Amiodarone 150mg/3ml Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

127 BRU09030217PS1 & BRU09030217PS2

Vastarel MR 35mg Tablet Trimetazidine HCl 35mg Les Laboratoires Servier Industrie, France (S1); Kotra Pharma (M) Sdn. Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 7 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

128 BRU09030219P Cataflam 1.5% Oral Drops Suspension

Diclofenac Sodium 15mg/ml Novartis Farma SpA, France Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

129 BRU09030222P Crestor 5mg Tablet Rosuvastatin Calcium 5mg IPR Pharmaceuticals Inc., Puerto Rico

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

130 BRU09030223P Crestor 20mg Tablet Rosuvastatin Calcium 20mg IPR Pharmaceuticals Inc., Puerto Rico

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

131 BRU09030224P Beprosone Ointment Betamethasone (as Dipropionate 0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading & Co 06 October 2020 till 05 October 2025

POM

132 BRU09030225P Beprosone Cream Betamethasone (as Dipropionate 0.064%) 0.05% w/w

HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading & Co 06 October 2020 till 05 October 2025

POM

133 BRU09030227P Pocin H Ear Drop Neomycin Sulphate B.P. 3,400 i.u.; Polymyxin B Sulphate B.P.10,000 i.u; Hydrocortisone B.P.10mg

Duopharma Manufacturing (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

134 BRU09030228P U-Closone Cream Clobetasone butyrate 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading & Co 06 October 2020 till 05 October 2025

POM

135 BRU09040229P Unasyn Powder for Oral Suspension 250mg/5ml

Sultamicillin (as tosilate) 250mg Pfizer Italia S.R.L., Latina, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

136 BRU09040230P Axcel Cefuroxime-250 Capsule Cefuroxime (as axetil) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

137 BRU09040232P0.5gV & BRU09040232P0.5gS

Stamaril Vaccine Live attenuated Yellow Fever Virus 17 D-204 strain (per 0.5ml - Not less than 1000 LD50 units of the virus)

Sanofi Pasteur, Marcel Mérieux, Marcy l’Etole, France & Sanofi Pasteur, Parc industriel d’Incarville, Val de Reuil, France; Sanofi Winthrop Industrie (SWI), Le Trait – France

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

138 BRU09040233P Voltaren Suppository 25mg Diclofenac (as Sodium) 25mg Delpharm Huningue S.A.S., France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

139 BRU09040234P Tidact Capsule 150mg Clindamycin (as hydrochloride) 150mg YSP Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

140 BRU09040235P Voltaren 75mg/3ml solution for injection

Diclofenac Sodium 75mg/3ml Lek Pharmaceuticals d.d, Slovenia

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

141 BRU09040237P Depo-Medrol Sterile Aqueous Suspension 40mg/ml

Methylprednisolone Acetate 200mg/5ml

Pfizer Manufacturing Belgium NV, Belgium

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

142 BRU09040241P Celebrex Capsule 200mg Celecoxib 200mg Pfizer Pharmaceutical LLC, Vega Baja Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

143 BRU09040242P Voltaren® SR Tablet 100mg Diclofenac sodium 100mg Novartis Farma SpA, Italy Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

144 BRU09040243P T3 Mycin Gel Clindamycin (as phosphate) 1.0% HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading & Co 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 8 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

145 BRU09040244P Cloderm Cream Clobetasone (as propionate) 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading & Co 06 October 2020 till 05 October 2025

POM

146 BRU09040245NP Bisacodyl Suppositories Bisacodyl (micronised) 10mg YSP Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 06 October 2020 till 05 October 2025

P

147 BRU09040246P U-Closone Ointment Clobetasol butyrate 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

148 BRU09040247P Nexium® IV 40mg Esomeprazole (as sodium) 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

149 BRU09050249P Vastarel 20mg Tablet Trimetazidine dihydrochloride 20mg Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

150 BRU09050250P Coversyl Plus Tablet Perindopril tert-butylamine 4mg, Indapamide 1.25mg

Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

151 BRU09050252P Glucobay Tablet 100mg Acarbose 100mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

152 BRU09050253P Benosone-N Ointment Betamethasone (as valerate 0.12% w/w) 0.1% w/w, Neomycin Sulphate 0.50%w/w

HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

153 BRU09050254P Benosone Ointment Betamethasone 0.1% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

154 BRU09050256P H-Cort Ointment Hydrocortisone 1% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

P

155 BRU09050257P T3 Mycin Lotion Clindamycin (as phosphate) 1.0% w/v HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

156 BRU09050258P Lobesol Cream Clobetasol (as propionate) 0.05%w/w Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

157 BRU09060259P Vaxcel Cefuroxime 1.5g Injection

Cefuroxime (as sodium) 1.5g Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 October 2020 till 05 October 2025

POM

158 BRU09060261P Beamoxy Capsule 250 Amoxycillin (as trihydrate) 250mg Upha Pharmaceutical Mfg (M) Sdn Bhd

K-Seri Pharma Sdn BHd 06 October 2020 till 05 October 2025

POM

159 BRU09060263P Voltaren 50mg Tablets Diclofenac Sodium 50mg Novartis Saglik, Gida ve Tarim Urunleri San. Ve Tic. A.S. Yenisehir Mahallesi, Turkey

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

160 BRU09060264P Voltaren 12.5mg Suppositories

Diclofenac Sodium 12.5mg Delpharm Huningue S.A.S., France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

161 BRU09060265P Voltaren 50mg Suppositories Diclofenac Sodium 50mg Delpharm Huningue S.A.S., France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

162 BRU09060266P Benosone Cream Betamethasone (as valerate) 0.1%w/w HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

163 BRU09060268P SW Betamethasone Cream Betamethasone (as valerate) 0.1%w/w Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

164 BRU09060269P Zorax Cream Aciclovir 5%w/w Sunward Pharmaceutical Pte Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

P

BDMCA/RMP/1220 Page 9 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

165 BRU09060270P Nexium mups 20mg Esomeprazole (as magnesium trihydrate) 20mg

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

166 BRU09060271P Ebutol-100 Tablet Ethambutol HCl 100mg Sunward Pharmaceutical Pte Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

167 BRU09060272P Neurontin Capsule 300mg Gabapentin 300mg Pfizer Pharmaceuticals LLC, Vega Baja Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

168 BRU09060274P Relenza® Rotadisks 5mg Zanamivir 5mg GlaxoSmithKline Australia Pty Ltd, Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

169 BRU09070275P Unasyn IM/IV 1.5g Sulbactam (as sodium 546.4mg) 500mg & Ampicillin (as sodium 1084.6mg) 1000mg

Haupt Pharma Latina S.r.l, Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

170 BRU09070277P Avaxim 80u Paediatric Inactivated Hepatitis A virus (GBM strain) 80u per 0.5ml

Sanofi Pasteur, Lyon, Pasteur Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

171 BRU09070279P Salazopyrin® EN-Tabs Sulfasalazine 500mg Recipharm Uppsala AB, Bjorkgatan 30, SE-751 82 Uppsala, Sweden.

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

172 BRU09070280P Zyloric® 100mg Tablet Allopurinol 100mg Aspen Port Elizabeth (Pty) Ltd, Republic of South Africa

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

173 BRU09070281P Orrepaste 0.1%w/w Triamcinolone Acetate 0.1%w/w HOE Pharmaceuticals Sdn Bhd, Malaysia.

G & H Trading Company 06 October 2020 till 05 October 2025

P

174 BRU09070282P SW Hydrocortisone Cream 1% w/w

Hydrocortisone acetate 1%w/w Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

175 BRU09070283P XanaxTM 0.25mg Tablet Alprazolam 0.25mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

176 BRU09070284P Nexium mups 40mg Esomeprazole (as magnesium trihydrate) 40mg

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

177 BRU09070286P XanaxTM 0.5mg Tablet Alprazolam 0.5mg Sanico N.V., Belgium Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

178 BRU09070287P Zolterol S/R Tablet 100mg Diclofenac Sodium 100mg Upha Pharmaceuticals Mfg (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

179 BRU09070290P Diamicron Tablet 80mg Gliclazide 80mg Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

180 BRU09070291NP Dulcolax Suppository 10mg Bisacodyl 10mg Istituto De Angeli S.r.l., Italy Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

P

181 BRU09070292P Clotrimazole Cream 1% w/w Clotrimazole 1% w/w Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

GSL

182 BRU09070293P Mucosolvon® 30mg Tablet Ambroxol hydrochloride 30mg PT Boehringer Ingelheim Indonesia, Bogor, Indonesia

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

183 BRU09080295P Pulmicort® Turbuhaler® 200mcg/dose

Budesonide (micronised) Ph Eur 200mcg/dose

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 10 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

184 BRU09080296P Epilim Intravenous 400mg/ vial

Sodium Valproate 400mg Sanofi S.p.A, Via Valcanello, 4 03012 Anagni, Italy

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

185 BRU09080298P Ebutol-400 Tablet Ethambutol HCl 400mg Sunward Pharmaceutical Pte Ltd, Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

186 BRU09080300PS1 & BRU09080300PS2

Diamicron MR Tablet 30mg Gliclazide 30mg Les Laboratoires Servier Industrie, France (S1) & Kotra Pharma (M) Sdn. Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

187 BRU09080301P Deltasolone Tablet 5mg Prednisolone 5mg Sunward Pharmaceutical Pte Ltd, Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

188 BRU09080302P Sunprox-275 Tablet Naproxen Sodium 275mg Sunward Pharmaceutical Pte Ltd, Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

189 BRU09080304P Prednisolone 1mg Tablet Prednisolone 1mg Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

190 BRU09080305NP Poro Suppository 250mg Paracetamol 250mg YSP Industries (M) Sdn Bhd, Malaysia

Asterix United Sdn Bhd 06 October 2020 till 05 October 2025

GSL & P

191 BRU09080307P Buscopan Tablet 10mg Hyoscine-N-butylbromide Delpharm Reims S.A.S,France MediPharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

192 BRU09080308P Atrovent N 20µg/ puff Metered Dose Inhaler

Ipratropium bromide anyhdrous 20mcg (as monohydrate 21mcg)

Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

193 BRU09080309P Fenagesic Capsule 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd, Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

194 BRU09080311P Carinox Capsule Pseudoephedrine sulphate 120mg; Loratadine 5mg

Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

195 BRU09090313P Typhim Vi Single Dose Purified Vi Capsular polysaccharides of Salmonella typhi (Ty2 strain) 25µg/0.5ml

Sanofi Pasteur, Campus Merieux, France & Sanofi Pasteur, Parc industrial d'Incarville, France

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

196 BRU09090314P Crestor 10mg Tablet Rosuvastatin Calcium 10mg AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

197 BRU09090317P Voltaren® SR 75 Tablet Diclofenac Sodium 75mg Novartis Farma S.p.A, Italy Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

198 BRU09090322P Actilyse® Treatment-Set Recombinant Human Tissue-type Plasminogen Activator (alteplase) 50mg

Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

199 BRU09090324P Trenlin SR Tablet 400mg Pentoxifylline 400mg Duopharma Manufacturing (Bangi) Sdn. Bhd., Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

200 BRU09090325NP Paratab Tablet 500mg Paracetamol 500mg Sunward Pharmaceutical Pte Ltd, Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

P

201 BRU09090327P Metalyse Injection 10,000units

Tenecteplase 10,000units (50mg) Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 11 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

202 BRU09090328NP Hemo RidTM Tablet Miconised Diosmin 450mg; Micronised Hesperidine 50mg

Duopharma Manufacturing (Bangi) Sdn. Bhd., Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

GSL

203 BRU09090329P Exforge Tablet 5mg/80mg Amlodipine 5mg (as besylate 6.94mg); Valsartan 80mg

Novartis Farmaceutica SA , Spain Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

204 BRU09100330P Imovax Polio Vaccine Inactivated Polio Virus: Type 1 (40DU/0.5mL), Type 2 (80DU/0.5mL), Type 3 32DU/0.5mL)

Sanofi Pasteur, Lyon, France ; Sanofi Winthrop Industrie, Le Trait (France)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

205 BRU09100331P Cloderm Ointment Clobetasol (as propionate) 0.05%w/w HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

206 BRU09100332P H-Cort Cream Hydrocortisone 1%w/w HOE Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

P

207 BRU09100334P Prelone Syrup 3mg/5ml Prednisolone Sunward Pharmaceutical Sdn Bhd, Malaysia.

G & H Trading Company 06 October 2020 till 05 October 2025

POM

208 BRU09100335P Ventolin Nebules 2.5mg/2.5ml Salbutamol Sulphate 2.5mg/2.5ml GlaxoSmithKline Australia Pty Ltd, Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

209 BRU09100336NP Sunquadin Lozenges Dequalinium Chloride Sunward Pharmaceutical Sdn Bhd, Malaysia.

G & H Trading Company 06 October 2020 till 05 October 2025

GSL

210 BRU09100337P Zoloft Tablet 50mg Sertraline (as hydrochloride) 50mg Pfizer Manufacturing Deutschland GmbH, Germany(Manufacturing, packaging, testing and release)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

211 BRU09100338NP Uphamol 250 Suspension (Fruity)

Paracetamol 250mg/5mL Upha Pharmaceuticals Mfg (M) Sdn Bhd, Malaysia

Bintang Ria Sdn Bhd 06 October 2015 till 05 October 2020

GSL

212 BRU09100339P XanaxTM 1mg Tablet Alprazolam 1mg Sanico NV Industriezone, Belgium

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

213 BRU09100340P Pontalon Capsule Mefenamic acid 250mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

214 BRU09100342NP Maalox Plus Tablet Aluminium hydroxide dried gel 200mg, Magnesium hydroxide 200mg, Simethicone 26.25mg (correspond to 25mg of polydiemthylsiloxane)

Sanofi S.P.A., S.S. 17 km 22, 67019 Scoppito (AQ) - Italy

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

GSL

215 BRU09100343P Neurontin 600mg Tablet Gabapentin 600mg Pfizer Pharmaceutical LLC, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

216 BRU09100345P LipitorTM 40mg Tablet Atorvastatin (as Calcium 43.38mg- crystalline) 40mg

Pfizer pharmaceuticals LLC, vega baja Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

217 BRU09100346NP Suniton Tablet Paracetamol 450mg, Orphenadrine Citrate 35mg

Sunward Pharmaceutical Pte Ltd, Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

P

BDMCA/RMP/1220 Page 12 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

218 BRU09100347P SCMC Plus Syrup 250mg/5mL S-carboxy-methylcysteine 250mg/5mL (Carbocisteine)

Duopharma Manufacturing (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 October 2020 till 05 October 2025

P

219 BRU09100348NP Glyprin Dispersible Tablet Aspirin 100mg, Glycine 45mg Duopharma Manufacturing (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

220 BRU09110350P Lantus® Solostar® 100units/ml Insulin Glargine (HOE 901) Sanofi-Aventis Deutschland GmbH, Germany

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

221 BRU09110354P LipitorTM 10mg Tablet Atorvastatin (as calcium 10.85mg - crystalline) 10mg

Pfizer pharmaceutical LLC, vega baja Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

222 BRU09110357PS2 Atrovent Unit Dose Vial (UDV) 250mcg/2ml

Ipratropium bromide anhydrous 250mcg (as monohydrate 261mcg)

Laboratoire Unither, France (S2) Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

223 BRU09110359P Allavin Expectorant Diphenhydramine HCl 14mg/5ml; Ammonium Chloride 135mg/5ml

Duopharma Manufacturing (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

224 BRU09110361NP Uphamol 500 Tablet Paracetamol 500mg Duopharma Manufacturing (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

P

225 BRU09110362P Carin Tablet 10mg Loratadine 10mg Duopharma Manufacturing (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

P

226 BRU09110363P Rhinathiol 2% for Children Syrup

Carbocisteine 100mg/5ml Unither Liquid Manufacturing, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

P

227 BRU09120365P Tienam IV Injection 500mg Imipenem (as monohydrate) 500mg & Cilastatin Sodium 500mg

Merck Sharp & Dohme Corp, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

228 BRU09120367P Dilantin 100mg Capsule Phenytoin Sodium Pfizer Pharmaceuticals LLC, Vega Baja, USA (Pfizer Vega Baja)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

229 BRU09120369P Oral Aid Lotion Lignocaine HCl 2.5%; Triamcinolone Acetonide 0.1%; Chlorhexidine HCl 0.5%

DUOPHARMA (M) SDN. BHD., Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

230 BRU09120375P Natrilix® SR Tablet Indapamide 1.5mg Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

231 BRU09120376NP Poro Suppository 125mg Paracetamol 125mg Y.S.P Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 06 October 2020 till 05 October 2025

GSL & P

232 BRU09120377P Vascor 40mg Film-coated Tablet

Simvastatin 40mg Upha Pharmaceuticals Mfg (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

233 BRU09120378P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg DUOPHARMA (M) SDN. BHD., Malaysia

K-Seri Pharma Sdn BHd 06 October 2020 till 05 October 2025

P

234 BRU09120379P Covastin Film-coated Tablet 10mg

Simvastatin 10mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

235 BRU09120380P CCM Metformin Hydrochloride Tablet 500mg

Metformin HCl 500mg DUOPHARMA (M) SDN. BHD., Malaysia

K-Seri Pharma Sdn BHd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 13 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

236 BRU09120381PS2 Co-Diovan 80/12.5 Film-coated Tablets

Valsartan 80mg; Hydrochlorothiazide 12.5mg

Novartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

237 BRU09120382P Rhinathiol® Promethazine syrup

Carbocisteine 100mg/5ml; Promethazine HCl 2.5mg/5ml

Unither Liquid Manufacturing, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

238 BRU09120383P Methotrexate CS injection 1000mg in 10ml

Methotrexate 1000mg/10ml Pfizer (Perth) Pty Limited, Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

239 BRU10010384P Zyloric 300mg Tablet Allopurinol 300mg Aspen Port Elizabeth (Pty) Ltd, Republic of South Africa

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

240 BRU10010385PS1 & BRU10010385PS2

Coversyl 4mg Tablet Perindopril tert-butylamine 4mg Les Laboratoires Servier Industrie, France (S1) & Kotra Pharma (M) Sdn Bhd., Malaysia

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

241 BRU10010386PS2 Atrovent Unit Dose Vial 0.5mg/2ml

Ipratropium bromide (as monohydrate) 500mcg/2ml

Laboratoires Unither, Amiens cedex, France (S2)

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

242 BRU10010387P Aspirin EC Tablet 100mg Acetylsalicylic acid 100mg Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

243 BRU10010388P Exforge Tablet 5mg/160mg Amlodipine 5mg (as besylate 6.94mg); Valsartan 160mg

Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

244 BRU10010390NPS3 Dulcolax 5mg Tablet Bisacodyl 5mg Delpharm Reims S.A.S., France (S3)

MediPharm Sdn Bhd 06 October 2020 till 05 October 2025

P

245 BRU10010391PS2 Diovan 80mg Tablet Valsartan 80mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

246 BRU10010392PS2 Co-Diovan 160/25 Film-coated Tablets

Valsartan 160mg; Hydrochlorothiazide 25mg

Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

247 BRU10010393P Chloramine 4 Syrup Chlorpheniramine maleate BP 4mg/5ml Duopharma Manufacturing (Bangi) Sdn. Bhd., Malaysia

K-Seri Pharma Sdn BHd 06 October 2015 till 05 October 2020

P

248 BRU10010397P Metformin Tablet 500mg Metformin HCl 500mg Sunward Pharmaceutical Pte Ltd, Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

249 BRU10010399P Seretide Accuhaler 50/500 Salmeterol 50mcg (as Xinafoate), Fluticasone propionate 500mcg

GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

250 BRU10020402P Solu-Medrol Sterile Powder 500mg

Methyprednisolone (as Sodium succinate) 500mg

Pfizer Manufacturing Belgium N.V., Belgium

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

251 BRU10020404P Imdex 60mg CR Tablet Isosorbide-5-Mononitrate 60mg Duopharma Manufacturing (Bangi) Sdn. Bhd., Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

252 BRU10020405P Vascor Tablet 20mg Simvastatin Upha Pharmaceuticals Mfg (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

253 BRU10020406P Combivent Unit Dose Vials Nebuliser Solution

Per 2.5ml - Ipratropium bromide (as monohydrate 522mcg) 500mcg; Salbutamol 2.5mg (as sulphate 3.013mg)

Laboratorie UNITHER , France Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 14 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

254 BRU10020407P Perinace Tablet 4mg Perindopril erbumine 4mg Duopharma Manufacturing (Bangi) Sdn. Bhd., Malaysia

K-Seri Pharma Sdn Bhd 06 October 2020 till 05 October 2025

POM

255 BRU10020409PS2 Diovan® 160mg Tablet Valsartan 160mg Novartis Farma S.A., Spain (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

256 BRU10020410P Etoposide CS 100mg/5ml Injection

Etoposide 100mg/5ml Pfizer (Perth) Pty Limited, Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

257 BRU10020411P Decondine Syrup Per 5ml - Triprolidine HCl 1.25mg; Pseudoephedrine HCl 30mg

Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

258 BRU10020412P Seretide Accuhaler 50/100 Salmeterol 50mcg (as Xinafoate), Fluticasone propionate 100mcg

GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

259 BRU10020413P Optizoline eye drops Tetrahydrozoline HCl 0.05%w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

260 BRU10020414P Sunadine Syrup Loratadine 5mg/5ml Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

P

261 BRU10020416P Lipitor 20mg Tablet Atorvastatin (Calcium) 20mg Pfizer Pharmaceutical LLC, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

262 BRU10020418P; BRU10020418PS2

Nitroderm TTS® 5 (5mg/24hr) Glyceryl Trinitrate/ nitroglycerin 25mg Novartis Pharma Stein AG, Switzerland; LTS Lohmann Therapie-Systeme AG, Germany (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

263 BRU10020421P Xatral XL Tablet 10mg Alfuzosin HCl 10mg Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

264 BRU10030423P Rhinathiol 5% Adult Expectorant Syrup

Carbocisteine 5g/100ml Unither Liquid Manufacturing, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

P

265 BRU10030426P Aromasin 25mg Tablet Exemestane 25mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

266 BRU10030427P Omesec Capsule 20mg Omeprazole 20mg Upha Pharmaceuticals Mfg (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 October 2020 till 05 October 2025

POM

267 BRU10030429P Polarax 2mg Tablet Dexchlorpheniramine maleate 2mg Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

268 BRU10030430P Pharmorubicin CS 50mg/25ml Epirubicin HCl 50mg/2ml Pfizer (Perth) Pty Limited, Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

269 BRU10030432P Cisplatin CS Injection 50mg/50ml

Cisplatin USP 50mg/50ml Pfizer (Perth) Pty Limited, Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

270 BRU10030433P Terramycin Ophthalmic Ointment

Per g - Oxytetracycline 5mg; Polymyxin B 10,000units

PT Pfizer (Indonesia), Indonesia Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

271 BRU10030435P Adriamycin CS Injection 50mg/25ml

Doxorubicin HCl 50mg/25ml Pfizer (Perth) Pty Limited, Australia

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

272 BRU10030436NP Maalox® Plus Suspension Per 5ml - Aluminium hydroxide 225mg; Magnesium hydroxide 200mg; Simethicone USP 25mg

Sanofi-aventis S.p.A., Origgio, Italy

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

GSL

BDMCA/RMP/1220 Page 15 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

273 BRU10030439P Prozine Syrup 5mg/5ml Promethazine HCl Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

274 BRU10030440P Olmetec Tablet 20mg Olmesartan Medoxomil 20mg Daiichi Sankyo Europe GmbH, Germany; Pfizer Manufacturing Deutschland GmbH, Germany (primary and secondary packaging site)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

275 BRU10040441P Diflucan Capsule 150mg Fluconazole 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

276 BRU10040442P Diflucan Capsule 100mg Fluconazole 100mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

277 BRU10040443P Diflucan Capsule 50mg Fluconazole 50mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

278 BRU10040444NP Cartril-S 500mg Capsule Glucosamine HCl 472.5mg equivalent to Glucosamine content in Glucosamine Sulphate 500mg

Duopharma Manufacturing (Bangi) Sdn. Bhd., Malaysia

K-Seri Pharma Sdn BHd 06 October 2020 till 05 October 2025

GSL

279 BRU10040445P Seretide Accuhaler 50/250 Salmeterol (as Xinafoate) 50mcg; Fluticasone Propionate 250mcg

GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

280 BRU10040452P; BRU10040452PS2

Nitroderm TTS® 10 Glyceral trinitrate/ nitroglycerin 50mg (10mg/24hr)

Novartis Pharma Stein AG, Switzerland; LTS Lohmann Therapie-Systeme AG, Germany (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

281 BRU10040453P Temodal Capsule 20mg Temozolomide 20mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

282 BRU10040454NP ColimixTM Syrup Per 5ml - Simethicone (activated dimethicone) 50mg; dicyclomine HCl 5mg

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

GSL

283 BRU10040455P Xepanicol® Eye Drops 0.5% Chloramphenicol 0.5% Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

284 BRU10040457PS2 Co-Diovan 160/12.5mg Tablets

Valsartan HCl 160mg; Hydrochlorothiazide 12.5mg

Novartis Farma S.p.A., Italy (S2) Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

285 BRU10040459P Atenolol 50mg Tablet Atenolol 50mg Sunward Pharmaceutical Pte Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

286 BRU10040460P Bromhexine Tablet 8mg Bromhexine HCl 8mg Sunward Pharmaceutical Pte Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

P

287 BRU10040461P Cytarabine CS injection 1000mg /10ml

Cytarabine 1000mg/10ml Pfizer (Perth) Pty, Ltd., Australia Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

288 BRU10040462P Exelon Oral Solution 2mg/ml Rivastigmine 2mg/ml (as hydrogen tartrate)

Delpharm Huningue S.A.S., France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 16 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

289 BRU10050463P Nebido 1000mg/4ml, Solution for Injection

Testosterone undecanoate 250mg(equiv. to testosterone 157.9mg)

Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

290 BRU10050464NP Mucosolvon Liquid 30mg/5ml Ambroxol Hydrochloride 30mg/5ml Delpharm Reims S.A.S., France Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

P

291 BRU10050466NP Uphamol Suspension 250 (Orange)

Paracetamol 250mg/5ml Upha Pharmaceuticals Mfg (M) Sdn Bhd, Malaysia

Bintang Ria Sdn Bhd 06 October 2015 till 05 October 2020

GSL & P

292 BRU10050468P Remicade Powder for Concentrate for Solution for Infusion 100mg/vial

Infliximab (cA2 IgG) 100mg/vial Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

293 BRU10050470P Pristinex Cream 2% w/w Ketoconazole 2%w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

GSL

294 BRU10050471P Zyvox Infusion Bag 600mg/300ml

Linezolid 600mg/300ml Fresenius Kabi Norge As, Halden, Norway

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

295 BRU10050473P Cervagem Pessary 1mg Gemeprost 1mg Ono Pharmaceutical Co Ltd, Japan

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

296 BRU10050474P Provinace Tablet 4mg Perindopril erbumine 4mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

297 BRU10050476P Dalacin C Capsule 150mg Clindamycin (as hydrochloride) 150mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

298 BRU10050477P Clozaril® Tablet 100mg Clozapine 100mg Novartis Saglik Gida ve Tarim Urunleri San. Ve Tic.A.S., Istanbul, Turkey

Medipharm Sdn Bhd 06 October 2015 till 05 October 2020

POM

299 BRU10050478P Telfast® 180mg Tablet Fexofenadine HCl 180mg PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

300 BRU10050479P Cozaar 100mg film-coated tablet

Losartan Potassium 100mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

301 BRU10060485P Allersin-F Tablet 4mg Chlorpheniramine maleate 4mg Sunward Pharmaceutical Pte. Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

P

302 BRU10060487P Asmol Syrup Salbutamol 2mg/5ml (as Sulphate 2.4mg)

Sunward Pharmaceutical Sdn. Bhd., Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

303 BRU10060491P Diatrol Tablet 2mg Loperamide HCl 2mg Sunward Pharmaceutical Sdn. Bhd., Malaysia

G & H Trading Company 06 October 2020 till 05 October 2025

POM

304 BRU10060492P Clozaril® 25mg Tablet Clozapine 25mg Novartis Saglik Gida ve Tarim Urunleri San. Ve Tic.A.S., Istanbul, Turkey

Medipharm Sdn Bhd 06 October 2015 till 05 October 2020

POM

305 BRU10060493P Olmetec 10mg Tablet Olmesartan medoxomil 10mg Daiichi Sankyo Europe GmbH, Germany; Pfizer Manufacturing Deutschland GmbH, Germany (primary and secondary packaging site)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 17 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

306 BRU10060494P Norvasc Tablet 5mg Amlodipine Besylate 5mg Pfizer Pharmaceuticals LLC, Vega Baja, P.R. 00693, United States [primary packaging site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

307 BRU10060495P Epilim 200mg/5ml Syrup Sodium Valproate 200mg Unither Liquid Manufacturing, France.

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

308 BRU10060496P Stilnox 10mg film-coated tablet

Zolpidem tartrate 10mg Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

309 BRU10060497P Hyosun syrup Hyoscine-N-Butylbromide (Scopolamine Butylbromide) 5mg/5ml

Sunward Pharmaceutical Pte. Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

310 BRU10060498P Nalol Tablet 40mg Propranolol HCl 40mg Sunward Pharmaceutical Pte. Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

311 BRU10060499P Exelon capsule 1.5mg Rivastigmine 1.5mg (as hydrogen tartrate 2.4mg)

Novartis Farmaceutica S.A., Spain

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

312 BRU10060500P Syntocinon 10IU solution for injection

Synthetic Oxytocin 10IU/ml Novartis Pharma Stein AG, Switzerland

Medipharm Sdn Bhd 06 October 2015 till 05 October 2020

POM

313 BRU10060501P Exelon capsule 6mg Rivastigmine 6mg (as hydrogen tartrate 9.6mg)

Novartis Farmaceutica S.A., Spain

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

314 BRU10060502P Zyvox film-coated tablet 600mg

Linezolid 600mg Pfizer Pharmaceuticals LLC, Puerto Rico, United States

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

315 BRU10060504P Sifrol tablet 0.125mg Pramipexole 0.088mg (eqv. to Pramipexole dihydrochloride monohydrate 0.125mg)

Boehringer Ingelheim Pharma GmbH & Co. Germany

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

POM

316 BRU10060505P Myfortic Gastro-Resistant tablet 180mg

Mycophenolic Acid 180mg (as Sodium Salt 192.4mg)

Novartis Pharma Produktions GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

317 BRU10070506P Phensedyl Dry Cough Linctus Per 5ml - Promethazine HCl 3.6mg; Pholcodine 4mg; Ephedrine HCl 7.2mg

Sanofi-Aventis Pakistan Limited, Pakistan

Medipharm Sdn Bhd 06 October 2015 till 05 October 2020

POM

318 BRU10070508P Norvasc Tablet 10mg Amlodipine Besylate 10mg Pfizer Pharmaceuticals LLC, Vega Baja, P.R. 00693, United States [primary packaging site: Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 18 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

319 BRU10070509P Pseudorine Tablet 60mg Pseudoephedrine HCl 60mg Sunward Pharmaceutical Pte. Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM (due to pack size

and single component of

product)320 BRU10070510P Laxodyl Tablet 5mg Bisacodyl 5mg Sunward Pharmaceutical Pte.

Ltd., Singapore G & H Trading Company 06 October 2020 till 05

October 2025GSL & P

321 BRU10070511P Decondine Tablet Tripolidine HCl 2.5mg; Pseudoephedrine HCl 60mg

Sunward Pharmaceutical Pte. Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

322 BRU10070512P Metoclopramide Tablet 10mg Metoclopramide HCl 10mg Sunward Pharmaceutical Pte. Ltd., Singapore

G & H Trading Company 06 October 2020 till 05 October 2025

POM

323 BRU10070513PS2 Desferal 500mg Desferrioxamine Methane Sulphonate Wasserburger Arzneimittelwerk GmbH, WasserburgGermany

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

324 BRU10070514P Anafranil® 25mg Tablet Clomipramine HCl 25mg Novartis Farma SpA., Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

325 BRU10070515P Zaricort Cream Miconazole Nitrate 2%w/w; Hydrocortisone 1%w/w

Xepa-Soul Pattinson (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 October 2020 till 05 October 2025

P

326 BRU10070516P Singulair® Tablet 10mg Montelukast (as sodium) 10mg Merck Sharp & Dohme Ltd., United Kingdom

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

327 BRU10070517P Singulair® Chewable Tablet 5mg

Montelukast (as sodium) 5mg Merck Sharp & Dohme Ltd., United Kingdom

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

328 BRU10070518P Lanoxin Injection 0.5mg/2ml Digoxin 0.5mg/2ml GlaxoSmithKline Manufacturing SpA., Italy

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

329 BRU10070519P Zithromax IV 500mg Azithromycin (as dehydrate) 500mg Pharmacia & Upjohn Company LLC, Kalamazoo, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

330 BRU10070520P Exelon® 4.5mg Capsule Rivastigmine 4.5mg (as Rivastigmine hydrogen tartrate 7.2mg)

Novartis Farmaceutica S.A., Spain

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

331 BRU10070521P Epilim Chrono 500mg Scored Film-coated Tablet

Sodium valproate 500mg (Sodium valproate 333mg & Valproic acid 145mg)

Sanofi Winthrop Industries, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

332 BRU10070522P Ritalin® Modified Release Capsule 30mg

Methylphenidate HCl 30mg Recro Gainsville LLC, USA Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

333 BRU10080523P Exforge 10/160mg FC Tablet Amlodipine 10mg (as besylate); Valsartan 160mg

Novartis Farmaceutica SA, Barbera del Valles (Barcelona) Spain

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 19 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

334 BRU10080529P Nasacort Aqueous Nasal Spray Triamcinolone Acetonide 55mcg/actuation

Aventis Pharma UK Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

335 BRU10080530P Ritalin 10mg Tablet Methylphenidate Hydrochloride 10mg Novartis Pharmaceuticals SA Spain

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

336 BRU10080531P Proctosedyl Suppositories Chinchocaine 5mg; Framycetin sulphate 10mg; Hydrocortisone 5mg; Aesculin 10mg

PT Aventis Pharma, Indonesia Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

337 BRU10080532P Prostin VR Paediatric® Sterile Solution 500mcg

Alprostadil 500mcg/ml Pharmacia & Upjohn Company, USA

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

338 BRU10080533P Lioresal 10mg Tablet Baclofen 10mg Novartis Farma SPA Italy Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

339 BRU10080534PS2 Fosamax 70mg Tablet Alendronate sodium 91.37 (as trihydrate) equivalent to alendronic acid 70mg

Aesica Pharmaceuticals GmbH, Germany (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

340 BRU10080535PS2 Telfast-D Extended Release Tablet

Fexofenadine hydrochloride 60mg ; Pseudoephedrine HCl 120mg

Sanofi Winthrop Industrie, France (S2)

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

341 BRU10090539P Singulair Tablet 4mg Montelukast 4mg (as sodium 4.16mg) Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

342 BRU10090540P Cozaar Tablet 50mg Losartan Potassium 50mg Merck Sharp & Dohme Ltd UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

343 BRU10090541P Lanoxin Paediatric/ Geriatric Elixir

Digoxin 0.05mg/mL Aspen Bad Oldesloe GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

344 BRU10090542PS2 Singulair Oral Granules 4mg Montelukast Sodium (free acid equivalent) 4mg

Patheon Manufacturing Services LLC, USA (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

345 BRU10090543P Frisium® 10mg Tablet Clobazam 10mg Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

346 BRU10090544PS2 Vytorin Tablet 10mg/20mg Ezetimibe 10mg: Simvastatin 20mg MSD International GmbH (Singapore Branch), Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

347 BRU10090545P Zocor 10mg Tablet Simvastatin 10mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

348 BRU10090546P Zocor 40mg Tablet Simvastatin 40mg Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

349 BRU10090549P Livial 2.5mg Tablet Tibolone 2.5mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

350 BRU10090550P Ritalin LA 20mg Capsules Methylphenidate Hydrochloride 20mg Recro Gainsville LLC, USA. Medipharm Sdn Bhd 06 October 2015 till 05 October 2020

POM

351 BRU10090551P Zoladex LA Depot Injection 10.8mg

Goserelin Acetate equivalent to Goserelin 10.8mg

AstraZeneca UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

352 BRU10090552P Harnal OCAS 400mcg Film-coated tablet

Tamsulosin (as hydrochloride 400mcg) 367mcg

Astellas Pharma Europe BV, The Netherlands

Medipharm Sdn Bhd 06 October 2020 till 05 October 2025

POM

BDMCA/RMP/1220 Page 20 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

353 BRU10090554P Proscar® Tablets 5mg Finasteride 5mg AIAC InternationalPharma LLC., Puerto Rico, USA.

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

354 BRU10090555PS1; Elomet Cream 0.1% Mometasone Furoate 0.1% Schering-Plough Labo N.V., Belgium (S1)

Zuellig Pharma (B) Sdn Bhd 06 October 2020 till 05 October 2025

POM

355 BRU10100556P Myfortic Gastro-Resistant tablet 360mg

Mycophenolic (as sodium) acid 360mg Novartis Pharma Produktions GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

356 BRU10100559P Exelon® Capsule 3mg Rivastigmine (as hydrogen tartrate) 3mg

Novartis Farmaceutica S.A. Spain Medipharm Sdn Bhd 28 October 2020 till 27 October 2025

POM

357 BRU10100560PS2 Arcoxia 60mg Film-coated tablet

Etoricoxib 60mg Rovi Pharma Industrial Services, S.A. , Spain (S2)

Zuellig Pharma (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

358 BRU10100561P Proctosedyl Ointment Cinchocaine hydrochloride 0.5%; Framycetin sulphate 1.0%; Hydrocortisone 0.5%; Aesculin 1.0%

Valeant Pharmaceuticals International Inc, Canada

Medipharm Sdn Bhd 28 October 2020 till 27 October 2025

POM

359 BRU10100562P Exelon® Patch 10 Rivastigmine Base 18mg / 10cm2 (9.5mg/24h)

LTS Lohmann Theraphie-System AG, Germany

Medipharm Sdn Bhd 28 October 2020 till 27 October 2025

POM

360 BRU10100563P Exelon® Patch 5 Rivastigmine base 9mg/5cm2 (4.6mg/24 hours)

LTS Lohmann Theraphie-System AG, Germany

Medipharm Sdn Bhd 28 October 2020 till 27 October 2025

POM

361 BRU10100564P ATGAM® Sterile Solution 50mg/mL (5mL amp)

Lymphocyte immune globulin, anti-thymocyte globulin (equine) 250mg/5mL

Pharmacia & Upjohn Company LLC, USA

Zuellig Pharma (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

362 BRU10100565PS1; BRU10100565PS2

Ezetrol 10mg Tablet Ezetimibe 10mg 1) MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico (S1); 2) MSD International GmbH (Singapore Branch), Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

363 BRU10100566PS2 Arcoxia 120mg Tablet Etoricoxib 120mg Rovi Pharma Industrial Services, S.A. , Spain (S2)

Zuellig Pharma (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

364 BRU10100567P Sun-Glizide Tablet 80mg Gliclazide 80mg Sunward Pharmaceutical Pte Ltd, Singapore

G & H Traidng Company 28 October 2020 till 27 October 2025

POM

365 BRU10100568P Zithromax Powder For Oral Suspension 200mg/5ml

Azithromycin (as dihydrate) 200mg/5ml Haupt Pharma Latina S.r.I., Italy Zuellig Pharma (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

366 BRU10100569P Fosamax Plus 70/2800mcg Tablets

Alendronic (as sodium 91.37) acid 70mg & (Vitamin D3 100,000 IU/g) Cholecalciferol 2800mcg

Rovi Pharma Industrial Services S.A., Madrid, Spain

Zuellig Pharma (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

367 BRU10100571P Arimidex 1mg tablet Anastrozole 1mg AstraZeneca Pharmaceuticals USA

Zuellig Pharma (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

368 BRU10100572P Casprin Enteric Microencapsulated Capsule 100mg

Aspirin 100mg Y.S.P. Industries (M) Sdn Bhd, Malaysia.

Asterix United (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

BDMCA/RMP/1220 Page 21 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

369 BRU10100573P Pontalon Film Coated Tablet 500mg

Mefenamic Acid 500mg Y.S.P. Industries (M) Sdn Bhd, Malaysia.

Asterix United (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

370 BRU10100576P Albutein® Solution for Infusion 25%

Albumin (Human) 25% Grifols Biologicals LLC., USA Hongkiat Trading & Company 28 October 2020 till 27 October 2025

POM

371 BRU10100578P Axol Liquid 3mg/ml Ambroxol Hydrochloride 3mg/ml Y.S.P. Industries (M) Sdn Bhd, Malaysia.

Asterix United (B) Sdn Bhd 28 October 2020 till 27 October 2025

P & POM

372 BRU10100579PS2 Vytorin™ Tablets 10mg/10mg Ezetimibe 10mg; Simvastatin 10mg MSD International GmbH (Singapore Branch), Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 28 October 2020 till 27 October 2025

POM

373 BRU10110581PS2 JanuviaTM Tablet 50mg Sitagliptin (as phosphate) 50mg Merck Sharp & Dohme Ltd, England (S2)

Zuellig Pharma (B) Sdn Bhd 24 November 2020 till 23 November 2025

POM

374 BRU10110582PS2 Arcoxia® 90mg Tablet Etrocoxib 90mg Rovi Pharma Industrial Services, S.A., Spain (S2)

Zuellig Pharma (B) Sdn Bhd 24 November 2020 till 23 November 2025

POM

375 BRU10110584P Zocor 20mg Film-coated Tablet

Simvastatin 20mg Merck Sharp & Dohme Ltd., Northumberland, UK

Zuellig Pharma (B) Sdn Bhd 24 November 2020 till 23 November 2025

POM

376 BRU10110585P Sifrol® Tablet 1mg Pramipexole dihydrochloride monohydrate 1mg (equivalent to 0.7mg pramipexole)

Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 24 November 2020 till 23 November 2025

POM

377 BRU10110587P; BRU10110587PS2

Metoclopramide Syrup 5mg/5ml

Metoclopramide hydrochloride 5mg/5ml

Sunward Pharmaceutical Pte Ltd, Singapore; Sunward Pharmaceutical Sdn Bhd, Malaysia (S2)

G & H Trading Company 24 November 2020 till 23 November 2025

POM

378 BRU10110588NP Suntacid Tablet Aluminium Hydroxide 250mg, Magnesium Trisilicate 250mg, Simethicone 30mg

Sunward Pharmaceutical Pte Ltd, Singapore

G & H Traidng Company 24 November 2020 till 23 November 2025

GSL

379 BRU10110590P Zoladex Depot 3.6mg/dose Goserelin (as acetate) 3.6mg AstraZeneca UK Ltd., UK Zuellig Pharma (B) Sdn Bhd 24 November 2020 till 23 November 2025

POM

380 BRU10110591P Voren Enteric Coated Tablet 25mg

Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 November 2020 till 23 November 2025

POM

381 BRU10110592P Oroxine Tablet 50mcg Levothyroxine Sodium 55.63mcg Aspen Bad Oldesloe GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 24 November 2020 till 23 November 2025

POM

382 BRU10110593P Voren Enteric Coated Tablet 50mg

Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 November 2020 till 23 November 2025

POM

383 BRU10110596P Beconase™ Aqueous Nasal Spray

Beclomethasone Dipropionate (as monohydrate)

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 November 2020 till 23 November 2025

POM

384 BRU10110597P Campto 40mg/2ml Injection Irinotecan hydrochloride trihydrate 40mg/2ml

Pfizer (Perth) Pty Ltd., Australia Zuellig Pharma (B) Sdn Bhd 24 November 2020 till 23 November 2025

POM

385 BRU10110598P Seroquel Tablet 25mg Quetiapine (as fumarate) 25mg AstraZeneca Pharmaceutical Co. Ltd., China

Zuellig Pharma (B) Sdn Bhd 24 November 2010 till 23 November 2015

POM

386 BRU10120599PS2 JanuviaTM Tablet 25mg Sitagliptin (as phosphate) 25mg Merck Sharp & Dohme Ltd, England (S2)

Zuellig Pharma (B) Sdn Bhd 29 December 2020 till 28 December 2025

POM

BDMCA/RMP/1220 Page 22 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

387 BRU10120600P Ritalin® LA Modified Release Capsule 40mg

Methylphenidate hydrochloride 40mg Recro Gainesville LLC, USA Medipharm Sdn Bhd 29 December 2020 till 28 December 2025

POM

388 BRU10120602P Orgalutran Solution for Injection 0.25mg/0.5ml

Ganirelix acetate 0.25mg/0.5ml Vetter Pharma-Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 29 December 2020 till 28 December 2025

POM

389 BRU10120604P Afrin Nasal Spray 0.05% Oxymetazoline Hydrochloride 0.05% PT. Merck Sharp Dohme Pharma Tbk, Indonesia

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28 December 2020

P

390 BRU10120605P Clarityne Tablet 10mg Loratadine 10mg PT. Merck Sharp Dohme Pharma Tbk, Indonesia

Zuellig Pharma (B) Sdn Bhd 29 December 2015 till 28 December 2020

P

391 BRU10120606P Frotin Pessaries Metronidazole 250mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 29 December 2020 till 28 December 2025

POM

392 BRU10120607P YSP Allopurinol Tablet 300mg Allopurinol 300mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 29 December 2020 till 28 December 2025

POM

393 BRU10120609P Vesicare Tablet 10mg Solifenacin Succinate 10mg Astellas Pharma Europe B.V., The Netherlands

Medipharm Sdn Bhd 29 December 2020 till 28 December 2025

POM

394 BRU10120611P Voren Suppositories 12.5mg Diclofenac Sodium 12.5mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 29 December 2020 till 28 December 2025

POM

395 BRU10120612P Flixonase Aqueous Nasal Spray 0.05%

Fluticasone propionate (micronised) 50mcg

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 29 December 2020 till 28 December 2025

POM

396 BRU10120613PS1; BRU10120613PS2

Esmeron® Injection 50mg/5ml (10mg/ml)

Rocuronium Bromide 50mg/5ml N.V. Organon, The Netherlands (S1); Siegfried Hameln GmbH, Germany (S2)

Zuellig Pharma (B) Sdn Bhd 29 December 2020 till 28 December 2025

POM

397 BRU10120616P Levitra® film-coated Tablet 5mg

Vardenafil 5mg (as monohydrochloride trihydrate)

Bayer AG., Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 29 December 2020 till 28 December 2025

POM

398 BRU10120617P IRESSATM Tablet 250mg Gefitinib 250mg Kagamiishi Plant, Nipro Pharma Corporation, Fukushima, Japan [packaging and labelling site: AstraZeneca Pharmaceutical Co. Ltd, Wuxi, Jiangsu China]

Zuellig Pharma (B) Sdn Bhd 29 December 2020 till 28 December 2025

POM

399 BRU11010619PS2 JanuviaTM Tablet 100mg Sitagliptin (as phosphate) 100mg Merck Sharp & Dohme Ltd, England (S2)

Zuellig Pharma (B) Sdn Bhd 26 January 2021 till 25 January 2026

POM

400 BRU11010621P Femara® 2.5mg Tablet Letrozole 2.5mg Novartis Pharma Stein AG, Switzerland

Medipharm Sdn Bhd 26 January 2021 till 25 January 2026

POM

401 BRU11010623P YSP Allopurinol Tablet 100mg Allopurinol 100mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 26 January 2021 till 25 January 2026

POM

402 BRU11010624P Elomet Ointment 0.1% Mometasone Furoate (as Anhydrous) USP 0.1%

PT. Merck Sharp Dohme Pharma Tbk, Indonesia

Zuellig Pharma (B) Sdn Bhd 26 January 2021 till 25 January 2026

POM

403 BRU11010626NP Poro Tablet 500mg Paracetamol 500mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 26 January 2021 till 25 January 2026

P

BDMCA/RMP/1220 Page 23 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

404 BRU11010627P Tegretol CR 200 Tablet Carbamazapine 200mg Novartis Farma S.p.A., Torree Annunziata, Italy

Medipharm Sdn Bhd 26 January 2021 till 25 January 2026

POM

405 BRU11010628P Oxy-Nase Paediatric Nasal Spray 0.025%

Oxymetazoline HCl 0.025% HOE Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 26 January 2021 till 25 January 2026

P

406 BRU11010629P TrandateTM Tablets 100mg Labetalol hyrdochloride 100mg Aspen Bad Oldesloe GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 26 January 2021 till 25 January 2026

POM

407 BRU11010631P Tegretol® CR 400 Tablet Carbamazapine 400mg Novartis Farma S.p.A., Torree Annunziata, Italy

Medipharm Sdn Bhd 26 January 2021 till 25 January 2026

POM

408 BRU11010636NP Bisacodyl Suppositories Bisacodyl 5mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 26 January 2021 till 25 January 2026

P

409 BRU11010637P EngerixTM-B 20 Adult Dose Suspension for Injection

Purified Hepatitis B Surface Antigen (HBsAg) 20mcg/ml

GlaxoSmithKline Biologicals SA, Rixensart Belgium; GlaxoSmithKline Biologicals S.A., Wavre Belgium (Formulation and filling in vials and syringes, labelling and packaging ); GlaxoSmithKline Biologicals, Saint Amand Les Eaux, France (Labelling and packaging in vials and syringes); GlaxoSmithKline Biologicals, Dresden, Germany (filling in syringes)

Zuellig Pharma (B) Sdn Bhd 26 January 2021 till 25 January 2026

POM

410 BRU11010638P HavrixTM720 Junior Vaccine Inactivated Hepatitis A virus antigen (HAV), HM175 strain 720 EL.U

GlaxoSmithKline Biologicals SA, Rixensart Belgium; GlaxoSmithKline Biologicals S.A., Wavre Belgium

Zuellig Pharma (B) Sdn Bhd 26 January 2021 till 25 January 2026

POM

411 BRU11010639P HiberixTM Vaccine Purified polyribosyl-ribitol-phosphate capsular polyaccharide (PRP) of Haemophilus influenza type b (Hib) 10µg covalently bound to 20-40µg tetanus toxoid

GlaxoSmithKline Biologicals SA, Belgium; GlaxoSmithKline Biologicals S.A., Saint-Amand-Les-EauxFrance

Zuellig Pharma (B) Sdn Bhd 26 January 2021 till 25 January 2026

POM

412 BRU11010640P Microgynon® 30 Tablet Levonorgestrel 0.15mg, Ethinylestradiol 0.03mg

Bayer Weimar GmbH und Co., KG, Germany

Zuellig Pharma (B) Sdn Bhd 26 January 2021 till 25 January 2026

POM

413 BRU11010642P Virless Tablets 200mg Acyclovir 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 26 January 2021 till 25 January 2026

POM

414 BRU11020643P Dalacin C 300mg Capsule Clindamycin (as Hydrochloride) 300mg Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 24 February 2021 till 23 February 2026

POM

415 BRU11020644P Tegretol® 200mg Tablet Carbamazepine 200mg Novartis Pharma S.p.A., Italy Medipharm Sdn Bhd 24 February 2021 till 23 February 2026

POM

BDMCA/RMP/1220 Page 24 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

416 BRU11020645P OroxineTM Tablet 100mcg Levothyroxine (as sodium) anhydrous 100mcg

Aspen Bad Oldesloe GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 24 February 2021 till 23 February 2026

POM

417 BRU11020647P Tegretol® 2% Syrup Carbamazepine 100mg/5ml Delpharm Huningue S.A.S., France

Medipharm Sdn Bhd 24 February 2021 till 23 February 2026

POM

418 BRU11020648P Glivec® 100mg Film-coated Tablet

Imatinib (as mesylate) 100mg Novartis Pharma Produktions GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 24 February 2021 till 23 February 2026

POM

419 BRU11020649P Sandostatin® Ampoules 0.05mg/ml

Octreotide (as acetate) 0.05mg/ml Novartis Pharma Stein AG., Switzerland

Medipharm Sdn Bhd 24 February 2021 till 23 February 2026

POM

420 BRU11020650P Levitra® film-coated Tablet 20mg

Vardenafil (as monochloride trihydrate) 20mg

Bayer AG., Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 24 February 2021 till 23 February 2026

POM

421 BRU11020652P Urosin® Film-coated Tablet 50mg

Atenolol 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 February 2021 till 23 February 2026

POM

422 BRU11020653P Ibuprofen Film-coated Tablet 400mg

Ibuprofen 400mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 February 2021 till 23 February 2026

P

423 BRU11020655P Voren Gel Diclofenac Sodium 10mg/g (as Diclofenac Acid Diethylamine)

Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 February 2021 till 23 February 2026

GSL

424 BRU11020656P Atacor 20mg Film-coated Tablets

Atorvastatin (as Calcium) 20mg Actavis hf., Iceland K-Seri Pharma Sdn Bhd 24 February 2016 till 23 February 2021

POM

425 BRU11020657P Dermosol Cream Clobetasol (as propionate) 0.5%w/w Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 February 2021 till 23 February 2026

POM

426 BRU11030660P Oxy-nase® Nasal Spray 0.05% Oxymetazoline HCl 0.05% HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 26 March 2021 till 25 March 2026

P

427 BRU11030662P Fucon Film Coated Tablet 10mg

Hysoscine-n-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 26 March 2021 till 25 March 2026

POM

428 BRU11030663P Betamethasone Tablet 0.5mg Betamethasone 0.5mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 26 March 2021 till 25 March 2026

POM

429 BRU11030664P Trivastal® Retard 50 Tablet Piribedil 50mg Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 26 March 2021 till 25 March 2026

POM

430 BRU11030667P Clarinase Syrup 5mg/5ml Per 5ml: Loratadine 5mg, Pseudoephedrine Sulphate 60mg

Sanofi Aventis Argentina S.A., Argentina

Zuellig Pharma (B) Sdn Bhd 26 March 2016 till 25 March 2021

P

431 BRU11030669PS2; BRU11030669PS3

Caelyx 2mg/ml Concentrate for Infusion

Doxorubicin HCl 2mg/ml GlaxoSmithKline Manufacturing S.P.A., Italy (S2); TTX Biopharm Company Ltd., Taiwan, R.O.C. (S3)

Zuellig Pharma (B) Sdn Bhd 26 March 2021 till 25 March 2026

POM

432 BRU11030670P Alkeran Tablet 2mg Melphalan 2mg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 26 March 2021 till 25 March 2026

POM

433 BRU11030671P Hyzaar Forte Tablet 100/25mg Losartan potassium 100mg, Hydrochlorothiazide 25mg

Merck Sharp & Dohme Ltd., UK Zuellig Pharma (B) Sdn Bhd 26 March 2021 till 25 March 2026

POM

434 BRU11030672P Avodart Soft Capsules 0.5mg Dutasteride 0.5mg GlaxoSmithKline Pharmaceuticals S.A., Poland

Zuellig Pharma (B) Sdn Bhd 26 March 2021 till 25 March 2026

POM

BDMCA/RMP/1220 Page 25 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

435 BRU11030674P Arixtra Injection 2.5mg/0.5ml Fondporinux sodium 2.5mg/0.5ml Aspen Notre Dame De Bondeville, France

Zuellig Pharma (B) Sdn Bhd 26 March 2021 till 25 March 2026

POM

436 BRU11040675P Puregon® 600iu/0.72ml Solution for Injection

Recombinant follicle-stimulating hormone (FSH) (follitrophin beta) [Org 32489] 600iu/0.72ml

Vetter Pharma-Fertigung GmbH & Co. KG., Mooswiesen, Revensburg, Germany and Vetter Pharma-Fertigung GmbH & Co. KG., Schutzenstrasse, Ravensburg, Germany

Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

437 BRU11040676PS1; BRU11040676PS2

Tazocin EF 4.5g Piperacillin (asmonohydrate) 4g; Tazobactam (as sodium) 0.5g

Wyeth Lederle S.r.I, Catania, Italy (S1); Pfizer Biotech Corporation,Hsinchu Plant, Taiwan-Republic of China (S2)

Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

438 BRU11040678P Euvax B Adult Vaccine Recombinant

Purified HBs-Ag 20mcg LG Chem, Ltd, Korea Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

439 BRU11040679P TrandateTM Injection 5mg/ml x 5ml

Labetalol HCl 25mg/5ml Hsinchu Plant of UBI Pharma Inc., Taiwan

Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

440 BRU11040681P Oxy-Nase Nasal Drops 0.05% Oxymetazolin Hydrochloride 0.05%w/v HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 30 April 2021 till 29 April 2026

P

441 BRU11040682P Sunolut Tablet 5mg Norethisterone 5mg Sunward Pharmaceutical Pte Ltd., Singapore

G & H Trading Company 30 April 2021 till 29 April 2026

POM

442 BRU11040683P Sandostatin® LAR® Injection 10mg

Octreotide 10mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

443 BRU11040684P Vfend TM Film-Coated Tablets 200mg

Voriconazole 200mg Pfizer Italia S.R.L, Italy Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

444 BRU11040685P Voren Suppositories 25mg Diclofenac Sodium 25mg Y.S.P Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

445 BRU11040688P Stablon Coated Tablet 12.5mg Tianeptine (as sodium) 12.5mg Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

446 BRU11040689P Shinoxol Tablet 30mg Ambroxol HCl 30mg Y.S.P Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

447 BRU11040690P Engerix-B 10 Adult Dose Suspension for Injection

Purified HBs-Ag 10mcg GlaxoSmithKline Biologicals SA., Rixensart Belgium; GlaxoSmithKline Biologicals S.A., WavreBelgium

Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

448 BRU11040691P Elosone Cream Mometasone Furoate 0.1%w/w HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 30 April 2021 till 29 April 2026

POM

BDMCA/RMP/1220 Page 26 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

449 BRU11040693P Cinna Tablet 25mg Cinnarizine 25mg Y.S.P Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

450 BRU11040695P RevoladeTM Film-coated Tablet 25mg

Eltrombopag 25mg [as free acid] (as olamine)

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), UK

Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

451 BRU11040696P Coversyl® Film-coated Tablet 10mg

Perindopril arginine 10mg (equiv to perindopril 6.790mg)

Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 30 April 2021 till 29 April 2026

POM

452 BRU11040697P Atorvastatin Winthrop® 20mg Film-coated Tablet

Atorvastatin 20mg (as calcium 20.68mg)

Saneca Pharmaceuticals a.s., Slovak Republic

Medipharm Sdn Bhd 30 April 2021 till 29 April 2026

POM

453 BRU11050699P Avamys® Nasal Spray Fluticasone furoate (micronised) 27.5µg /spray

Glaxo Operations UK Ltd, United Kingdom

Zuellig Pharma (B) Sdn Bhd 25 May 2021 till 24 May 2026

POM

454 BRU11050700PS1; BRU11050700PS2

Tetraxim Vaccine Purified diphteria toxoid ≥ 30IU; purified tetanus toxoid ≥ 40IU; Bordetella pertusis antigens: Adsorbed purified pertusis toxoid 25µg, Adsorbed purified filamentous haemagglutinin 25µg ; Inactivated poliomyelitis virus: Type 1 40 D units, Type 2 8 Dunits, Type 3 32 Dunits.

Sanofi Pasteur, Campus Merieux, France; Sanofi Pasteur, Parc industriel d'Incarville, France

Zuellig Pharma (B) Sdn Bhd 25 May 2021 till 24 May 2026

POM

455 BRU11050701P Depo-Provera Vial 150mg/3ml Medroxyprogesterone acetate 150mg Pfizer Manufacturing Belgium N.V., Belgium

Zuellig Pharma (B) Sdn Bhd 25 May 2021 till 24 May 2026

POM

456 BRU11050702P Benzhexol Tablet 2mg Benzhexol HCl 2mg Sunward Pharmaceutical Pte Ltd., Singapore

G & H Trading Company 25 May 2021 till 24 May 2026

POM

457 BRU11050703P Levitra Film-coated Tablets 10mg

Vardenafil (as monohydrochloride trihydrate) 10mg

Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 25 May 2021 till 24 May 2026

POM

458 BRU11050705NP Upha B6 10 Tablet Pyridoxine HCl 10mg Upha Pharmaceutical Mfg (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 25 May 2016 till 24 May 2021

P

459 BRU11050706P Zofran Injection Flexi-Amp Ampoules

Ondansetron HCl Dihydrate 8mg/4ml GlaxoSmithKline Australia Pty Ltd.m Australia

Zuellig Pharma (B) Sdn Bhd 25 May 2021 till 24 May 2026

POM

460 BRU11050707P Caverject 20mcg Powder and solvent for injection

Alprostadil 20µg Pfizer Manufacturing Belgium N.V., Belgium

Zuellig Pharma (B) Sdn Bhd 25 May 2021 till 24 May 2026

POM

461 BRU11050708NP Essentiale Forte N Capsule Phospholipids fatty mass 392mg (equivalent to 300mg phospholipids from soya beans containing 76% of (3-sn-phosphatidyl) choline)

A. Nattermann & Cie. GmbH., Germany

Medipharm Sdn Bhd 25 May 2021 till 24 May 2026

GSL

462 BRU11050710P Coveram Tablets 5mg/5mg Perindopril arginine 5mg (equiv. to perindopril 3.395mg); Amlodipine 5mg (as besilate 6.935mg)

Servier (Ireland) Industries Ltd., Ireland

Zuellig Pharma (B) Sdn Bhd 25 May 2021 till 24 May 2026

POM

BDMCA/RMP/1220 Page 27 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

463 BRU11050712P Tracrium Injection 25mg/2.5ml

Atracurium besylate 25mg/2.5ml GlaxoSmithKline Manufactuirng S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 25 May 2021 till 24 May 2026

POM

464 BRU11060715P Oxy-Nase Paediatric Nasal Drop 0.025%w/v

Oxymetazoline HCl 0.025% HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 02 July 2021 till 01 July 2026

POM

465 BRU11060716P Vfend 50mg film-coated Tablet

Voriconazole 50mg Pfizer Italia S.R.L., Italy Zuellig Pharma (B) Sdn Bhd 02 July 2021 till 01 July 2026

POM

466 BRU11060718P MyleranTM Tablets 2mg Busulphan 2mg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 02 July 2021 till 01 July 2026

POM

467 BRU11060720P Virless Tablet 800mg Acyclovir 800mg Y.S.P. Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 02 July 2021 till 01 July 2026

POM

468 BRU11060721P Atorvastatin Winthrop® 40mg Tablet

Atorvastatin 40mg (as Calcium 41.36mg)

Saneca Pharmaceuticals a.s., Slovak Republic

Medipharm Sdn Bhd 02 July 2021 till 01 July 2026

POM

469 BRU11060722P Propecia 1mg Tablet Finasteride 1mg Merck Sharp & Dohme, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 02 July 2016 till 01 July 2021

POM

470 BRU11060723P Seroquel XR Extended-Release Tablets 50mg

Quetiapine 50mg (as fumarate 57.560mg)

AstraZeneca Pharmaeuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 02 July 2021 till 01 July 2026

POM

471 BRU11070724P Vesicare® 5mg Tablet Solifenacin Succinate 5mg Astella Pharma Europe B.V., The Netherlands

Medipharm Sdn Bhd 27 July 2021 till 26 July 2026

POM

472 BRU11070727P SW Bena-Expectorant Per 5ml: Diphenhydramine HCl 10mg, Ammonium Chloride 102mg, Sodium Citrate 46mg

Sunward Pharmaceutical Pte Ltd., Singapore

G&H Trading Company 27 July 2021 till 26 July 2026

POM

473 BRU11070729P Priorix TM Composition of Priorix™ per dose (0.5ml): Live attenuated measles virus (Schwarz strain) ≥103.0 CCID50, Live attenuated mumps virus (RIT4385 strain) ≥103.7 CCID50, Live attenuated rubella virus (Wistar RA 27/3 strain) ≥103.0 CCID50

GlaxoSmithKline Biologicals s.a., Belgium; FIDIA Farmaceutici S.p.a., Italy; GSK Biologicals’ Marietta site Corixa Corporation dba GSK Biologicals North America, Marietta Pennsylvania USA

Zuellig Pharma (B) Sdn Bhd 27 July 2016 till 26 July 2021

POM

474 BRU11070730P Mirena® Intrauterine System 20mcg/24hr

Levonorgestrel 52mg Bayer Oy, Finland Zuellig Pharma (B) Sdn Bhd 27 July 2021 till 26 July 2026

POM

475 BRU11070733P ZofranTM Injection 4mg/2ml Ondansetron 4mg/2ml (as HCl dihydrate)

GlaxoSmithKline Australia Pty Ltd., Australia

Zuellig Pharma (B) Sdn Bhd 27 July 2021 till 26 July 2026

POM

476 BRU11070734P Syntometrine® Injection 5IU/ml Ampoule

Oxytocin 5IU/ml Novartis Pharma Steing AG., Switzerland

Medipharm Sdn Bhd 27 July 2016 till 26 July 2021

POM

477 BRU11070735P Elosone Ointment 0.1%w/w Mometasone furoate 0.1% w/w HOE Pharmaceuticals Sdn Bhd., Malaysia

G & H Trading Company 27 July 2021 till 26 July 2026

POM

BDMCA/RMP/1220 Page 28 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

478 BRU11070736P Coveram 5/10mg Tablet Perindopril arginine 5mg (equiv. to 3.395mg perindopril) and amlodipine 10mg (as besilate 13.870mg)

Servier (Ireland) Industries Ltd, Ireland

Zuellig Pharma (B) Sdn Bhd 27 July 2021 till 26 July 2026

POM

479 BRU11070737P ZofranTM Tablets 8mg Ondansetron 8mg (as HCl dihydrate) Aspen Bad Oldesloe GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 27 July 2021 till 26 July 2026

POM

480 BRU11070738PS1; BRU11070738PS2

Diamicron® MR 60mg Tablet Gliclazide 60mg Les Laboratoires Servier Industrie, France (S1); Kotra Pharma (M) Sdn. Bhd, Malaysia (S2)

Zuellig Pharma (B) Sdn Bhd 27 July 2021 till 26 July 2026

POM

481 BRU11070740P Tracrium Injection 50mg/5ml Atracurium Besylate 50mg/5ml GlaxoSmithKline Manufacturing S.p.A., Parma, Italy

Zuellig Pharma (B) Sdn Bhd 27 July 2021 till 26 July 2026

POM

482 BRU11070741P Coralan® Tablet 7.5mg Ivabradine 7.5mg (as HCl 8.085mg) Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 27 July 2021 till 26 July 2026

POM

483 BRU11080742P; BRU11080742PS2

Aclasta 5mg/100ml Solution for Infusion

Zoledronic acid (anhydrous) 5mg (as zoledronic acid monohydrate 5.33mg)

Novartis Pharma Stein AG., Switzerland; Fresenius Kabi Austria GmbH, Austria (S2)

Zuellig Pharma (B) Sdn Bhd 25 August 2021 till 24 August 2026

POM

484 BRU11080743P Lanoxin Tablet 250mcg Digoxin 250mcg Aspen Bad Oldesloe GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 25 August 2021 till 24 August 2026

POM

485 BRU11080744P Lanoxin PG Tablet 0.0625mg Digoxin 0.0625mg Aspen Bad Oldesloe GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 25 August 2021 till 24 August 2026

POM

486 BRU11080745P Glivec® 400mg Film-coated Tablet

Imatinib (as mesylate) 400mg Novartis Pharma Stein AG., Switzerland

Zuellig Pharma (B) Sdn Bhd 25 August 2021 till 24 August 2026

POM

487 BRU11080748P Campto 100mg/5ml Injection Irinotecan hydrochloride trihydrate Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 25 August 2016 till 24 August 2021

POM

488 BRU11080749P Econazine Cream Econazole nitrate 1% w/w, Triamcinolone actonide 0.1% w/w

Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24 August 2021

POM

489 BRU11080750P Frotin Film Coated 200mg Tablet

Metronidazole 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24 August 2021

POM

490 BRU11080751P Urosin Film Coated Tablet 100mg

Atenolol 100mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24 August 2021

POM

491 BRU11080753P Fukole Capsule 150mg Fluconazole 150mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 25 August 2021 till 24 August 2026

POM

492 BRU11080754P CoAprovel Tablet 300/25mg Irbesartan 300mg, Hydrochlorothiazide 25mg

Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 25 August 2021 till 24 August 2026

POM

493 BRU11080757P Orphenadol® Tablet Orphenadrine Citrate 50mg, Paracetamol 325mg

Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 25 August 2021 till 24 August 2026

P

494 BRU11080758P Loramide Capsule 2mg Loperamide HCl 2mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 25 August 2016 till 24 August 2021

POM

BDMCA/RMP/1220 Page 29 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

495 BRU11080759P VOREN Suppositories 50mg Diclofenac Sodium 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 25 August 2021 till 24 August 2026

POM

496 BRU11080760P Decan Tablet 0.75mg Dexamethasone 0.75mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 25 August 2021 till 24 August 2026

POM

497 BRU11090762P Properazine Tablet 5mg Prochlorperazine maleate 5mg Sunward Pharmaceutical Pte Ltd, Singapore

G & H Trading Company 27 September 2021 till 26 September 2026

POM

498 BRU11090763P Infanrix HexaTM Composition of reconstiitiuted DTPa-HBV-IPV+Hib Vaccine per dose (0.5ml): Diphteria toxoid min. 30 I.U; Tetanus toxoid min. 40 I.U; Pertusis toxoid (PT) 25µg; Filamentous haemagglutinin (FHA), adsorbed 25µg; Pertactin, adsorbed 8µg; r-DNA Hepatitis B surface antigen (HBsAg purified) 10µg; Inactivated poliomyeltis virus type I 40 DU, Inactivated poliomyeltis virus type II 8DU, Inactivated poliomyeltis virus type III 32 DU;Conjugate of Haemophilus influenza type b capsular polysaccharide (PRP) and tetanus toxoid 10µg PRP and ~25µg T

GlaxoSmithKline Biologicals SA, Rixensart Belgium; GlaxoSmithKline Biologicals S.A., Saint-Amand-Les-EauxFrance; GlaxoSmithKline Biologicals S.A., WavreBelgium;

Zuellig Pharma (B) Sdn Bhd 27 September 2021 till 26 September 2026

POM

499 BRU11090764P Eloxatin 5mg/ml Concentrate for Solution for Infusion (10ml)

Oxaliplatin 50mg/10ml Sanofi-Aventis Deutschland GmbH, Germany

Medipharm Sdn Bhd 27 September 2021 till 26 September 2026

POM

500 BRU11090765P Eloxatin 5mg/ml Concentrate for Solution for Infusion (20ml)

Oxaliplatin 100mg/20ml Sanofi-Aventis Deutschland GmbH, Germany

Medipharm Sdn Bhd 27 September 2021 till 26 September 2026

POM

501 BRU11090766P InfanrixTM-IPV Vaccine Composition per dose (0.5ml): Diphteria toxoid (DT), adsorbed min. 30 I.U; Tetanus toxoid (TT), adsorbed min. 40 I.U; Pertusis toxoid (PT), adsorbed 25µg; Filamentous haemagglutinin (FHA), adsorbed 25µg; Pertactin, adsorbed 8µg; Inactivated poliomyeltis virus type I 40 DU, Inactivated poliomyeltis virus type II 8DU, Inactivated poliomyeltis virus type III 32 DU

GlaxoSmithKline Biologicals SA, Belgium (Manufacturer of finished products); GlaxoSmithKline Biologicals S.A. France (Repacker of finished products, additional facilities for formulation, filling and quality control testing sites)

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26 September 2021

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

502 BRU11090767P Sandimmun Neoral® Oral Solution 100mg/ml

Ciclosporin A 100mg/ml Delpharm Huningue S.A.S., France

Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26 September 2021

POM

503 BRU11090768P Hyzaar® Tablet 50/12.5mg Losartan Potassium 50mg, Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme, Northumberland, UK

Zuellig Pharma (B) Sdn Bhd 27 September 2021 till 26 September 2026

POM

504 BRU11090769P Hyzaar® Plus Tablet 100/12.5mg

Losartan Potassium 100mg, Hydrochlorothiazide 12.5mg

Merck Sharp & Dohme, Northumberland, UK

Zuellig Pharma (B) Sdn Bhd 27 September 2021 till 26 September 2026

POM

505 BRU11090770P Flebogamma 5% DIF Solution for Infusion (100mL)

Human Normal Immunoglobulin 50mg/ml

Instituo Grifols S.A., Barcelona, Spain; Grifols Biologicals LLC (GBLLC), USA (alternative site for the preparation of Fraction II + III)

Hongkiat Trading & Company 27 September 2016 till 26 September 2021

POM

506 BRU11090771P Seroquel XR Tablets 200mg Quetiapine (as fumarate) 200mg AstraZeneca Pharmaeuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 27 September 2021 till 26 September 2026

POM

507 BRU11090772P Diabetmin Film-coated Tablet 500mg

Metformin HCl 500mg Hovid Bhd, Perak, Malaysia G & H Trading Company 27 September 2021 till 26 September 2026

POM

508 BRU11090773P Tidact Gel 1% Clindamycin 10mg/g (as phosphate 11.9mg/g)

Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 27 September 2021 till 26 September 2026

POM

509 BRU11090774P Daunoblastina Injection 20mg Daunoribicin Hydrochloride 20mg Actavis S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 September 2016 till 26 September 2021

POM

510 BRU11090775P Fucon Capsule 10mg Hyoscine-N-butylbromide 10mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 27 September 2021 till 26 September 2026

POM

511 BRU11090776P Virless Cream Acyclovir 50mg/g Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 27 September 2016 till 26 September 2021

P

512 BRU11090778P Hovasc Tablet 5mg Amlodipine 5mg (as besilate 6.90mg) Hovid Bhd, Malaysia G & H Trading Company 27 September 2021 till 26 September 2026

POM

513 BRU11100779P Pariet® Tablet 20mg Sodium Rabeprazole 20mg Bushu Pharmaceuticals Ltd, Japan. , Japan

MediPharm Sdn Bhd 31 October 2021 till 30 October 2026

POM

514 BRU11100780P Pariet® Tablet 10mg Sodium Rabeprazole 10mg Bushu Pharmaceuticals Ltd, Japan. , Japan

MediPharm Sdn Bhd 31 October 2021 till 30 October 2026

POM

515 BRU11100782P Gardasil Vaccine HPV Type 6 L1 protein 20mcg/0.5ml; HPV Type 11 L1 protein 40mcg/0.5ml; HPV Type 16 L1 protein 40mcg/0.5ml; HPV Type 18 L1 protein 20mcg/0.5ml

Merck Sharp & Dohme Corp., USA

Zuellig Pharma (B) Sdn Bhd 31 October 2021 till 30 October 2026

POM

516 BRU11100784P Sandostatin® ampoules 0.1mg/ml

Octreotide (as acetate) 0.1mg/ml Novartis Pharma Stein A.G., Switzerland

Medipharm Sdn Bhd 31 October 2021 till 30 October 2026

POM

517 BRU11100785P Atorvastatin Winthrop® 10mg film-coated Tablets

Atorvastatin 10mg (as calsium 10.34mg)

Saneca Pharmaceuticals a.s., Slovak Republic

MediPharm Sdn Bhd 31 October 2021 till 30 October 2026

POM

BDMCA/RMP/1220 Page 31 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

518 BRU11100787P Coveram Tablet 10mg/5mg Perindopril arginine 10mg (eqv. To Perindopril 6.790mg); Amlodipine 5mg (as besilate 6.935mg)

Servier (Ireland) Industries Ltd., Ireland

Zuellig Pharma (B) Sdn Bhd 31 October 2021 till 30 October 2026

POM

519 BRU11100788P Coversyl® Fim-coated Tablet 5mg

Perindopril arginine 5mg (eqv. Perindopril 3.395mg)

Les Laboratoires Servier Industrie, Gidy, France

Zuellig Pharma (B) Sdn Bhd 31 October 2021 till 30 October 2026

POM

520 BRU11100789P Myonal 50mg Tablet Eperisone Hydrochloride 50mg Eisai Co., Ltd, Saitama Prefecture, Japan

MediPharm Sdn Bhd 31 October 2016 till 30 October 2021

POM

521 BRU11100790P VarilrixTM Live attenuated varicella virus (OKA strain)

GlaxoSmithKline Biologicals SA, Rixensart, Belgium (Manufacturer of finished product); (Corixa Corporation dba GlaxoSmithKline Vaccines, USA (formulation, filling, lyophilisation and QC testing)GlaxoSmithKline Biologicals SA, Rixensart, Belgium (Manufacturing site for Water for Injection (WFI) diluents in syringe and ampoule); Delpharm Tours, Chambray-lès-Tours, France (Manufacturing site for Water for Injection (WFI) diluents in ampoules); GlaxoSmithKline Biologicals S.A., Wavre, Belgium & GlaxoSmithKline Biologicals, Saint-Amand-Les-Eaux, France & Centre de Recherche et de Nouvelles Applications (CRNA) SA, Belgium (Manufacturing site for final packaging operations)

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30 October 2021

POM

BDMCA/RMP/1220 Page 32 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

522 BRU11100791P Coveram Tablet 10mg/10mg Perindopril arginine 10mg (eqv. To Perindopril 6.790mg); Amlodipine 10mg (as besilate 13.870mg)

Servier (Ireland) Industries Ltd., Ireland

Zuellig Pharma (B) Sdn Bhd 31 October 2021 till 30 October 2026

POM

523 BRU11100792P Voker Film Coated Tablet 20mg

Famotidine 20mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 31 October 2016 till 30 October 2021

POM

524 BRU11100794P Clarinase Repetabs Loratadine 5mg, Pseudoephedrine sulphate 120mg

Schering Plough Labo N.V., Belgium

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30 October 2021

P(due to pack size and to facilitated

access public)525 BRU11100795P Euthyrox® Tablet 25mcg Levothyroxine sodium 25mcg Merck KGaA., Darmstadt,

Germany [primary & secondary packaging site: Corden Pharma GmbH, Germany]

Zuellig Pharma (B) Sdn Bhd 31 October 2016 till 30 October 2021

POM

526 BRU11100796P Concor® 2.5mg Tablet Bisoprolol hemifumarate 2.5mg Merck Healthcare KGaA., Darmstadt, Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2021 till 30 October 2026

POM

527 BRU11110797P OnglyzaTM Tablet 2.5mg Saxagliptin 2.5mg (as HCl anhydrous 2.79mg)

Bristol-Myers Squibb Company, Indiana, USA

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23 November 2021

POM

528 BRU11110798P OnglyzaTM Tablet 5mg Saxagliptin 5mg (as HCl anhydrous 5.58mg)

Bristol-Myers Squibb Company, Indiana, USA

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23 November 2021

POM

529 BRU11110799P Sandostatin® LAR® Injection 20mg

Octreotide (as acetate) 20mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2021 till 23 November 2026

POM

530 BRU11110800P Sandostatin® LAR® Injection 30mg

Octreotide (as acetate) 30mg Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 November 2021 till 23 November 2026

POM

531 BRU11110802P GardasilTM Vaccine (Syringe) Per 0.5ml dose - HPV Type 6 L1 protein 20mcg; HPV Type 11 L1 protein 40mcg; HPV Type 16 L1 protein 40mcg; HPV Type 18 L1 protein 20mcg

Merck Sharp & Dohme Corp., USA

Zuellig Pharma (B) Sdn Bhd 24 November 2021 till 23 November 2026

POM

532 BRU11110803P Nexavar® 200mg Film-coated Tablets

Sorafenib Tosylate 200mg Bayer AG., Leverkusen, Germany; Bayer Healthcare Manufacturing S.r.l., Italy

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23 November 2021

POM

533 BRU11110809P Dalacin CTM Sterile Solution 150mg/ml x 2ml ampoule

Clindamycin Phosphate 300mg Pfizer Manufacturing Belgium N.V., Puurs, Belgium

Zuellig Pharma (B) Sdn Bhd 24 November 2021 till 23 November 2026

POM

BDMCA/RMP/1220 Page 33 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

534 BRU11110812P Euthyrox® Tablet 100mcg Levothyroxine sodium 100mcg Merck KGaA., Darmstadt, Germany; [primary & secondary packaging site: Corden Pharma GmbH, Germany]

Zuellig Pharma (B) Sdn Bhd 24 November 2016 till 23 November 2021

POM

535 BRU11110813P Ketipinor Film-coated Tablet 200mg

Quetiapine 200mg (as fumarate 230.36mg)

Orion Corporation, Espoo, Finland

Hongkiat Trading & Company 24 November 2016 till 23 November 2021

POM

536 BRU11110814P YSP Prednisolone 5mg Tablet Prednisolone 5mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 November 2016 till 23 November 2021

POM

537 BRU11110815P Granocyte® 34 Injection Lenograstim (rHug-CSF) 33.6 million IU (equiv. to 263 mcg)/ vial

Sanofi Winthrop Industrie, France

MediPharm Sdn Bhd 24 November 2021 till 23 November 2026

POM

538 BRU11120816P Euvax B Pediatric Vaccine Recombinant (10mcg/0.5ml)

Purified HBs-Ag 10mcg/0.5ml LG Chem, Ltd, Korea Zuellig Pharma (B) Sdn Bhd 22 December 2021 till 21 December 2026

POM

539 BRU11120817P Puregon® 300IU/0.36 ml Solution for Injection

Recombinant follicle-stimulating hormone (FSH) (follitrophin beta) [Org 32489] 600iu/0.72ml

Vetter Pharm-Fertigung GmbH & Co. KG., Schutzenstrasse, Ravensburg, Germany; Vetter Pharm-Fertigung GmbH & Co. KG., Mooswiesen, Ravensburg, Germany

Zuellig Pharma (B) Sdn Bhd 22 December 2021 till 21 December 2026

POM

540 BRU11120818P Clarityn Syrup Loratadine 1mg/ml PT. Merck Sharp Dohme Pharma Tbk, Indonesia

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21 December 2021

P

BDMCA/RMP/1220 Page 34 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

541 BRU11120819P0.5gV & BRU11120819P0.5gS

SynflorixTM Vaccine 1 dose (0.5ml) contains: Pneumococcal polysaccharide serotype 11,2 - 1mcg, Pneumococcal polysaccharide serotype 41,2 - 3mcg, Pneumococcal polysaccharide serotype 51,2 - 1mcg, Pneumococcal polysaccharide serotype 6B1,2 - 1mcg, Pneumococcal polysaccharide serotype 7F1,2 - 1mcg, Pneumococcal polysaccharide serotype 9V1,2 - 1mcg, Pneumococcal polysaccharide serotype 141,2 - 1mcg, Pneumococcal polysaccharide serotype18C1,3 - 3mcg, Pneumococcal polysaccharide serotype 19F1,4 - 3mcg, Pneumococcal polysaccharide serotype 23F1,2 - 1mcg Note: 1 adsorbed on aluminium phosphate - 0.5mg Al3+; 2 conjugated to protein D (derived from non-typeable Haemophilus influenza) carrier protein - 9-16mcg; 3 conjugated to tetanus toxoid carrier protein - 5-10mcg; 4 conjugated to diphtheria toxoid carrier protein - 3-6mcg

GlaxoSmithKline Biologicals SA, Rixensart Belgium; Glaxo SmithKline Biologicals SA, Saint-Amand-Les-EauxFrance

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21 December 2021

POM

542 BRU11120820P VentolinTM EvohalerTM Salbutamol (as sulphate 120.5mcg) 100mcg

Glaxo Wellcome S.A., Burgos, Spain

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21 December 2021

POM

543 BRU11120822P RevoladeTM Film-coated Tablets 50mg

Eltrombopag olamine (eq. to Eltrombopag 50mg as Eltrombopag free acid)

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations) United Kingdom

Zuellig Pharma (B) Sdn Bhd 22 December 2021 till 21 December 2026

POM

544 BRU11120823P Coversyl® Plus 5mg Perindopril arginine 5mg (as besilate 3.395mg); Indapamide 1.25mg

Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21 December 2021

POM

545 BRU11120826NP Arcalion® 200mg Tablet Sulbutiamine 200mg Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 22 December 2016 till 21 December 2021

GSL

BDMCA/RMP/1220 Page 35 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

546 BRU11120827PS2 Methycobal Injection 500mcg/ml

Mecobalamin 500mcg Nipro Pharma Corporation Ise Plant, Matsusaka-shi, Mie, Japan (S2)

MediPharm Sdn Bhd 22 December 2016 till 21 December 2021

POM

547 BRU11120828P Flebogamma® 5% DIF Solution for Infusion (200ml)

Human Normal Immunoglobulin 10g/200mL (50mg/ml)

Instituto Grifols, S.A., Spain; Grifols Biologicals LLC (GBLLC), USA (alternative site for the preparation of Fraction II + III).

Hongkiat Trading 22 December 2016 till 21 December 2021

POM

548 BRU11120829P Shintamet film coated Tablet Cimetidine 400mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21 December 2021

POM

549 BRU11120830P Dermafin cream 1% Terbinafine Hydrochloride 1%w/w Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21 December 2021

GSL

550 BRU11120831P Pontalon Tablet 250mg Mefenamic Acid 250mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21 December 2021

POM

551 BRU11120832P Clopivid Tablet 75mg Clopidogrel 75mg (as hydrogen sulphate 97.90mg)

Hovid Bhd, Malaysia G & H Trading Company 22 December 2021 till 21 December 2026

POM

552 BRU11120833P Shincort Injection “Yung Shin” 10mg/ml

Triamcinolone Acetonide 50mg/5ml Yung Shin Pharmaceutical Ind. Co. Ltd., Taiwan ROC

Asterix United (B) Sdn Bhd 22 December 2016 till 21 December 2021

POM

553 BRU11120834P Hovasc Tablet 10mg Amlodipine 10mg (as Besylate 13.8mg) Hovid Bhd, Malaysia G & H Trading Company 22 December 2021 till 21 December 2026

POM

554 BRU11120835P Indomen Capsule 25mg Indomethacin 25mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21 December 2021

POM

555 BRU11120836P Clomiphene Tablet 50mg Clomiphene citrate 50mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 22 December 2016 till 21 December 2021

POM

556 BRU11120837P Primacor® 10mg/10ml Injection

Milrinone 10mg/10ml (as lactate) Delpharm Dijon, France MediPharm Sdn Bhd 22 December 2021 till 21 December 2026

POM

557 BRU11120838NP Champs D-Worms 6 Chewable Tablet (Chocolate)

Albendazole 200mg Duopharma Manufacturing (Bangi) Sdn Bhd

Hongkiat Trading & Company 22 December 2016 till 21 December 2021

GSL

558 BRU11120839P Epilim® 200 Enteric Coated Tablets

Sodium Valproate 200mg Sanofi-Aventis S.A., Spain MediPharm Sdn Bhd 22 December 2021 till 21 December 2026

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

559 BRU12010840P InfanrixTM-IPV+Hib Vaccine (DTPa-IPV+Hib)

1 dose (0.5ml) contains: Diphteria toxoid (DT) Min 30 I.U.; Tetanus toxoid (TT) Min 40 I.U.; Pertussis toxoid (PT) Min 25mcg; Filamentous haemagglutinin (FHA) 25mcg; Pertactin (69Kda Outer membrance protein) 8mcg; Inactivated Polio Virus Type 1 (Mahoney seed) 40DU; Inactivated Polio Virus Type 2 (MEF-1 seed) 8DU; Inactivated Polio Virus Type 3 (Saukett seed) 32DU; Conjugate of purified capsular polysaccharide (10mcg) of Haemophilus influenza type b covalently bound to approximately 30mcg to 50 mcg tetanus toxoid

GlaxoSmithKline Biologicals SA, Rixensart Belgium; GlaxoSmithkline Biologicals S.A., France

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31 January 2022

POM

560 BRU12010841P Cardura XLTM tablet 4mg Doxazosin Mesylate 4mg Pfizer Pharmaceuticals LLC, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31 January 2022

POM

561 BRU12010842P Valdoxan® 25mg film-coated tablet

Agomelatine 25mg Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31 January 2022

POM

562 BRU12010843P Zofran Tablet 4mg Ondansetron (as Hydrochloride Dihydrate) 4mg

Aspen Bad Oldesloe GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31 January 2022

POM

563 BRU12010844P Flebogamma® 5% DIF Solution for Infusion (50ml)

Human Normal Immunoglobulin 2.5g/50mL (50mg/ml)

Instituto Grifols, S.A., Spain; Grifols Biologicals LLC (GBLLC), USA (alternative site for the preparation of Fraction II + III).

Hongkiat Trading & Co 01 February 2017 till 31 January 2022

POM

564 BRU12010845P Coralan® Tablet 5mg Ivabradine 5mg eq. to 5.39mg ivabradine hydrochloride

Les Laboratoires Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31 January 2022

POM

565 BRU12010846P Seroquel XR tablets 300mg Quetiapine (as fumarate) 300mg Astrazeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 01 February 2022 till 31 January 2027

POM

566 BRU12010847P Seroquel XR tablets 400mg Quetiapine (as fumarate) 400mg Astrazeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 2 February 2022 till 31 January 2027

POM

567 BRU12010850P Enapril tablet 10mg Enalapril maleate 10mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 01 February 2017 till 31 January 2022

POM

568 BRU12010851NP Princi-B Fort® tablet Thiamin mononitrate 250mg, Pyridoxine hydrochloride 250mg & Cyanocobalamin 1mg

Olic (Thailand) Ltd, Thailand MediPharm Sdn Bhd 01 February 2022 till 31 January 2027

P

569 BRU12010852P Antifungal Cream 2% Miconazole Nitrate 20mg/g (2% w/w) Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 01 February 2017 till 31 January 2022

GSL

570 BRU12010853P Concor® 5mg tablet Bisoprolol hemifumarate 5mg Merck Healthcare KGaA, Darmstadt, Germany

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31 January 2022

POM

BDMCA/RMP/1220 Page 37 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

571 BRU12010854P Ketipinor film-coated tablet 100mg

Quetiapine (as fumarate 115.13mg) 100mg

Orion Corporation, Finland Hongkiat Trading & Co 01 February 2017 till 31 January 2022

POM

572 BRU12010855P Euthyrox® Tablet 50mcg Levothyroxine sodium 50mcg Merck KGaA, Germany; Merck S.A. de C.V., Mexico (packaging/labelling) [primary & secondary packaging site: Corden Pharma GmbH, Germany]

Zuellig Pharma (B) Sdn Bhd 01 February 2017 till 31 January 2022

POM

573 BRU12010856NP Panadol Suspension 250mg/5ml

Paracetamol 250mg/5ml Smithkline Beecham, Philippines; Kuehne+Nagal Sdn Bhd, Selangor, Malaysia (secondary repacker)

Kingston Beverage & Creamery Sdn Bhd

01 February 2017 till 31 January 2022

GSL

574 BRU12010857P Targocid® Injection 200mg Teicoplanin 200mg/3ml (200mg/vial) Sanofi S.p.A, Italy MediPharm Sdn Bhd 01 February 2017 till 31 January 2022

POM

575 BRU12020860P Yucomy Tablet 200mg Ketoconazole 200mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 1 March 2017 till 28 February 2022

POM

576 BRU12020862P Ketipinor Film-coated Tablet 25mg

Quetiapine (as fumarate 28.78mg) 25mg

Orion Corporation, Finland Hongkiat Trading & Co 1 March 2017 till 28 February 2022

POM

577 BRU12020863P Taxotere 20mg/1ml concentrate for solution for infusion

Docetaxel (as trihydrate) 20mg/ml Sanofi-Aventis Deutschland GmbH, Germany

MediPharm Sdn Bhd 1 March 2017 till 28 February 2022

POM

578 BRU12020864P Zanidip® Tablet 10mg Lercanidipine Hydrochloride 10mg (eq. to 9.4mg Lercanidipine)

Recordati Industria Chimica & Farmaceutica S.p.A, Italy

Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28 February 2022

POM

579 BRU12020865PS1 Nifedipine LA Tablet 30mg Nifedipine 30mg Valpharma International S.p.A, Italy (S1)

G & H Trading Company 1 March 2017 till 28 February 2022

POM

580 BRU12020866P Apidra® Solostar® 100units/ml, Solution for Injection in a Pre-filled Pen

Insulin Glulisine 100units/ml Sanofi-Aventis Deutschland GmbH, Germany

MediPharm Sdn Bhd 1 March 2017 till 28 February 2022

POM

581 BRU12020867P Zavedos CS Injection vials Idarubicin hydrochloride 1mg/ml Pfizer (Perth) Pty Limited, Australia

Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28 February 2022

POM

582 BRU12020870P Lyrica™ 150mg Capsules Pregabalin 150mg Pfizer Manufacturing Deutshland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 1 March 2017 till 28 February 2022

POM

583 BRU12030871NP Panadol® Menstrual Caplet Paracetamol 500mg & Pamabrom 25mg

Sterling Drug (Malaya) Sdn Bhd., Malaysia

Kingston Beverage & Creamery Sdn Bhd

30 March 2017 till 29 March 2022

P

584 BRU12030872NP Panaflex® Pain Relief Patch Glycol Salicylate 1.5%w/w, L-Menthol 1.0% w/w, DL-Camphor 0.5%w/w, DL-A-Tocopherol Acetate 0.3%w/w

Teh Seng Pharmaceutical Mfg Co., Ltd., Taiwan, ROC

Kingston Beverage & Creamery Sdn Bhd

30 March 2017 till 29 March 2022

GSL

585 BRU12030874P BrilintaTM 90mg F/C Tablet Ticagrelor 90mg AstraZeneca AB., Sweden Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March 2022

POM

BDMCA/RMP/1220 Page 38 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

586 BRU12030875P DetrusitolTM SR Capsule 4mg Tolterodine L-Tartrate 4mg (equivalent to Tolterodine 2.74mg)

Catalent Pharma Solutions LLC, USA

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March 2022

POM

587 BRU12030876NP Ellgy Corns & Warts Treatment Solution

Salicylic acid 17%w/v HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 30 March 2017 till 29 March 2022

GSL

588 BRU12030877P Puregon® 900IU/1.08ml Solution for Injection

Follitropin Beta (Recombinant follicle-stimulating hormone FSH) [Org 32489]

Vetter Pharma-Fertigung GmbH & Co. KG., Schutzenstrasse, Ravensburg, Germany; Vetter Pharma-Fertigung GmbH & Co. KG., Mooswiesn2, Ravensburg, Germany; Vetter Pharma-Fertigung GmbH & Co. KG., Eisenbahnstrasse, Langenargen, Germany; Vetter Pharma-Fertigung GmbH & Co. KG., Holbeinstrasse, Ravensburg, Germany

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March 2022

POM

589 BRU12030879P Methotrexate CS injection 50mg in 2ml

Methotrexate 50mg/2ml Pfizer (Perth) Pty Limited, Australia

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March 2022

POM

590 BRU12030880NP Aqua Cream Emulsifying Wax 8% w/w, White Soft Paraffin 12%w/w, Liquid Paraffin 8%w/w

Duopharma Manufacturing (Bangi) Sdn. Bhd.

Hongkiat Trading & Company 30 March 2017 till 29 March 2022

GSL

591 BRU12030881P CelebrexTM 400mg Capsule Celecoxib 400mg Pfizer Pharmaceuticals LLC., vega Baja Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March 2022

POM

592 BRU12030882P Cancidas Powder for Injection 50mg/vial

Caspofungin (as acetate) 50mg/vial Laboratoires Merck Sharp & Dohme Chibret, France

Zuellig Pharma (B) Sdn Bhd 30 March 2017 till 29 March 2022

POM

593 BRU12030883P Axcel Dextrozine Syrup Dextromethorphan Hydrobromide 15mg/5ml; Promethazine HCl 3.6mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 March 2017 till 29 March 2022

POM

594 BRU12040884P Dilantin Steri Vials 250mg in 5ml

Phenytoin Sodium 250mg/5ml Actavis Italy S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April 2022

POM

595 BRU12040885P Jevtana® 60mg Concentrate and Solvent for Solution for Infusion

Cabazitaxel 60mg/1.5ml Sanofi-Aventis Deutschland GmbH, Germany

Medipharm Sdn Bhd 30 April 2017 till 29 April 2022

POM

596 BRU12040886P HycamtinTM Hard Capsule 1mg Topotecan 1mg (as hydrochloride) GlaxoSmithKline Manufacturing S.p.A., Parma, Italy

Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April 2022

POM

597 BRU12040887NP Panadol Suspension 120mg/5ml

Paracetamol 120mg/5ml SmithKline Beecham, Cainta Rizal, Philippines

Kingston Beverage & Creamey Sdn Bhd

30 April 2017 till 29 April 2022

GSL

598 BRU12040888P Cancidas Powder for Injection 70mg/vial

Caspofungin (as acetate) 70mg/vial Laboratoires Merck Sharp & Dohme Chibret, France

Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April 2022

POM

BDMCA/RMP/1220 Page 39 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

599 BRU12040889PS1 & BRU12040889PS2

Nasonex Aqueous Nasal Spray 0.05%

Mometasone furorate monohydrate, micronized 0.05%

Schering-Plough Labo N.V., Belgium (S1) & MSD International GmbH (Singapore Branch), Singapore (S2)

Zuellig Pharma (B) Sdn Bhd 30 April 2017 till 29 April 2022

POM

600 BRU12040891P Axcel Diprodin Elixir Diphenhydramine HCl 12.5mg/5ml; Ephedrine HCl 6mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April 2022

POM

601 BRU12040892NP Axcel Paracetamol-120 Syrup (Cherry)

Paracetamol 120mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April 2022

GSL

602 BRU12040893P Axcel Clobetasol 0.05% Cream Clobetasol propionate 0.05%w/w Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April 2022

POM

603 BRU12040894P Axcel Tridine Syrup Triprolidine HCl 1.25mg/5ml; Pseudoephedrine HCl 30mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April 2022

P

604 BRU12040895P Axcel Lignocaine Sterile Gel 2%w/w

Lignocaine HCl (Equiv. to anhydrous HCl) 2g/100g

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 April 2017 till 29 April 2022

POM

605 BRU12050897P VfendTM IV 200mg Voriconazole 200mg Pharmacia & Upjohn Company, USA (Repacker Fareva Amboise, France)

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May 2022

POM

606 BRU12050898P Lamictal Dispersible Tablet 5mg

Lamotrigine 5mg GlaxoSmithKline Pharmaceuticals SA., Poznan, Poland (Repacker - GlaxoSmithKline Australia Pty Ltd., ViCtoria, Australia)

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May 2022

POM

607 BRU12050899P HycamtinTM Hard Capsule 0.25mg

Topotecan 0.25mg (as hydrochloride) GlaxoSmithKline Manufacturing S.p.A., Parma, Italy

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May 2022

POM

608 BRU12050900P AeriusTM Syrup 0.5mg/ml Desloratadine 0.5mg/ml Schering-Plough Labo N.V., Belgium

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May 2022

POM

609 BRU12050901NP Flamazine Cream 1% w/w Silver Sulfadiazine 1.0%w/w Recipharm Parets S.L., Barcelona, Spain

Mc Quipp Technisell Marketing Sdn Bhd

24 May 2017 till 23 May 2022

P

610 BRU12050902P AeriusTM Tablet 5mg Desloratadine 5mg Schering-Plough Labo N.V., Belgium

Zuellig Pharma (B) Sdn Bhd 24 May 2017 till 23 May 2022

POM

611 BRU12050903NP Panadol® ActiFast Caplets Paracetamol 500mg GlaxoSmithKline Dungravan Ltd, Ireland (Repacker - Sterling Drug (Malaya) Sdn Bhd., Malaysia

Kingston Beverage & Creamery Sdn Bhd

24 May 2017 till 23 May 2022

GSL & P

612 BRU12050904P Vaxcel Heparin Sodium Injection 5000 IU/ml x 5ml

Heparin Sodium (Bovine mucosa) 25,000/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 24 May 2017 till 23 May 2022

POM

613 BRU12060908P Methycobal Tablets 500mcg Mecobalamin JP 0.5mg Bushu Pharmaceuticals Ltd, Japan

Medipharm Sdn Bhd 30 June 2017 till 29 June 2022

GSL

BDMCA/RMP/1220 Page 40 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

614 BRU12060909P LyricaTM 75mg Capsules Pregabalin 75mg Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June 2022

POM

615 BRU12060910NP Panadol® Soluble Tablet 500mg

Paracetamol 500mg GlaxoSmithKline Australia Pty Ltd, Ermington, NSW, Australia

Kingston Beverage & Creamery Sdn Bhd

30 June 2017 till 29 June 2022

GSL & P

616 BRU12060911NP Panadol For Children Tablets 120mg

Paracetamol 120mg Sterling Drug (Malaya) Sdn Bhd., Selangor, Malaysia

Kingston Beverage & Creamery Sdn Bhd

30 June 2017 till 29 June 2022

P

617 BRU12060912P Canesten GYN 1 Day Therapy Vaginal Tablet 0.5g

Clotrimazole 500mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June 2022

P

618 BRU12060913P Casodex Tablet 50mg Bicalutamide 50mg Corden Pharma GmbH, Plankstadt, Germany

Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June 2022

POM

619 BRU12060915NP Drapolene Cream Cetrimide 0.2%w/w; Benzalkonium Chloride Solution 0.02%w/w (equiv. to Benzalkonium Chloride 0.01%w/w)

GlaxoSmithKline Pharmacuetical SA, Poznan, Poland

Kingston Beverage & Creamery Sdn Bhd

30 June 2017 till 29 June 2022

GSL

620 BRU12060916P Rhewlin Gel 1%w/w Diclofenac Diethylamine equiv. to Diclofenac Sodium 1%w/w

Beacons Pharmaceutical Pte Ltd, Singapore

Hongkiat Trading & Company 30 June 2017 till 29 June 2022

GSL

621 BRU12060917P Efexor® XR 37.5mg Capsule Venlafaxine Hydrochloride 37.5mg Pfizer Ireland Pharmacueticals, Kildare, Republic of Ireland

Zuellig Pharma (B) Sdn Bhd 30 June 2017 till 29 June 2022

POM

622 BRU12070918P Beclomet Nasal Aqua 50mcg/dose Nasal Spray

Beclomethasone dipropionate 50mcg/dose

Orion Corporation, Kuopio, Finland

Hongkiat Trading & Company 30 July 2017 till 29 July 2022

POM

623 BRU12070920NP Panadol® Biconvex Film-coated Tablet 500mg

Paracetamol 500mg Sterling Drug (Malaya) Sdn Bhd., Selangor, Malaysia

Kingston Beverage & Creamery Sdn Bhd

30 July 2017 till 29 July 2022

P (50's, 3 x 10's & 15 x 10's)

624 BRU12070921NP ENO Ginger Fruit Salt Sodium Bicarbonate Coarse 1.462g (34.002%w/w); Sodium Bicarbonate Fine 0.487g (11.316%w/w); Citric Acid Anhydrous 1.834g (42.640%w/w); Sodium Carbonate Anhydrous 0.425g (9.892%w/w)

Sterling Drug (Malaya) Sdn Bhd., Selangor, Malaysia

Kingston Beverage & Creamery Sdn Bhd

30 July 2017 till 29 July 2022

GSL

625 BRU12070922NP ENO Fruit Salt Sodium Bicarbonate Coarse 1.489g (34.63%w/w); Sodium Bicarbonate Fine 0.496 (11.54%w/w); Citric Acid Anhydrous 1.873g (43.58%w/w); Sodium Carbonate Anhydrous 0.43g (10.00%w/w)

Sterling Drug (Malaya) Sdn Bhd., Selangor, Malaysia

Kingston Beverage & Creamery Sdn Bhd

30 July 2017 till 29 July 2022

GSL

626 BRU12070923P Coversyl Plus 10mg/2.5mg Tablet

Perindopril arginine 10mg (equiv. to 6.79mg perindopril); Indapamide 2.5mg

Servier (Ireland) Industries Ltd, Ireland

Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022

POM

BDMCA/RMP/1220 Page 41 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

627 BRU12070924P RotarixTM oral Suspension Human rotavirus RIX4414 strain, not less than 106.0 CCID50

GlaxoSmithKline Biological SA, Belgium (Manufacturer of finished products); GlaxoSmithKline Biologicals S.A.,Wavre, Belgium (Additional facility for formulation& filling)

Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022

POM

628 BRU12070926NP Bepanthen® Ointment Dexpanthenol 5%w/w GP Genzech Produktions GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022

GSL

629 BRU12070927P Axcel Hydrocortisone Cream Hydrocortisone (micronised) 1% w/w Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 July 2017 till 29 July 2022

P

630 BRU12070928P Sevoflurane Inhalation Anaesthetic Liquid 100%

Sevoflurane 100% (1ml/ml) Baxter Healthcare Corporation, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 July 2017 till 29 July 2022

POM

631 BRU12080932P Efexor XR 75mg Capsule Venlafaxine (as HCl) 75mg Pfizer Ireland Pharmaceuticals, Kildare, Republic of Ireland

Zuellig Pharma (B) Sdn Bhd 29 August 2017 till 28 August 2022

POM

632 BRU12090933P Xarelto® Film-coated Tablet 10mg

Rivaroxaban 10mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26 September 2022

POM

633 BRU12090937P Telfast 6mg/ml Oral Suspension

Fexofenadine Hydrochloride 6mg/ml Sanofi-Aventis Farmceutica Ltd, Vila Areiao Suzano-SP-Brasil

Medipharm Sdn Bhd 27 September 2017 till 26 September 2022

POM

634 BRU12090938P Glucophage® XR 750mg Extended Release Tablet

Metformin HCl 750mg Merck Healthcare KGaA, Germany; Merck Sante SAS, Semoy, France

Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26 September 2022

POM

635 BRU12090939P Glucophage® Tablet 500mg Metformin HCl 500mg Merck Sante SAS, Semoy, France Zuellig Pharma (B) Sdn Bhd 27 September 2017 till 26 September 2022

POM

636 BRU12100941P; BRU12100941PS2

FragminTM Solution for Injection 5,000IU (anti-Xa)/0.2ml

Dalteparin Sodium 5,000IU (anti-Xa)/0.2ml

Vetter Pharma-Fertigung GmbH & Co., Germany; Pfizer Manufacturing Belgium NV, Puurs, Belgium (S2)

Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30 October 2022

POM

637 BRU12100942P Prostin E2TM Vaginal Tablet 3mg

Dinoprostone 3mg Sanico N.V., Turnhout, Belgium Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30 October 2022

POM

638 BRU12100943NP Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 2.5% Dextrose

Dextrose 2.5g; Sodium Chloride 538mg; Sodium Lactate 448mg; Calcium Chloride dihydrate 18.3mg; Magnesium Chloride Hexhydrate 5.08mg

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 31 October 2017 till 30 October 2022

GSL

639 BRU12100944NP Potassium Chloride Tablet 600mg (Slow release)

Potassium Chloride 600mg Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 31 October 2017 till 30 October 2022

P

640 BRU12100945NP Anucare Suppositories Zinc Oxide 300mg; Balsam Peru 50mg; Benzyl Benzoate 33mg

Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 31 October 2017 till 30 October 2022

GSL

BDMCA/RMP/1220 Page 42 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

641 BRU12100947P Illiadin Decongestant Nasal Drops

Oxymetazoline Hydrochloride 0.01% Merck KGaA, Germany Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30 October 2022

P

642 BRU12100948P Renvela (Sevelamer Carbonate) Tablet 800mg

Sevelamer Carbonate 800mg Genzyme Ireland Limited, Ireland Medipharm Sdn Bhd 31 October 2017 till 30 October 2022

POM

643 BRU12100949P Lyrica Capsules 50mg Pregabalin 50mg Pfizer Manufacturing Deutschland GmbH, Freiburg, Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2017 till 30 October 2022

POM

644 BRU12100950P QvarTM 100 Inhaler Beclomethasone dipropionate 100mcg per inhalation

3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 31 October 2021 till 30 October 2026

POM

645 BRU12100951P Prograf Capsule 0.5mg Tacrolimus 0.5mg Astellas Ireland Ltd, Ireland Medipharm Sdn Bhd 31 October 2017 till 30 October 2021

POM

646 BRU12110953P; BRU12110953PS2

FragminTM Solution for Injection 2,500IU (anti-Xa)/0.2ml, Single dose syringe

Dalteparin Sodium 2,500IU (anti-Xa)/0.2ml

Vetter Pharma-Fertigung GmbH & Co., Germany; Pfizer Manufacturing Belgium NV, Puurs, Belgium (S2)

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26 November 2022

POM

647 BRU12110954P Efexor XR 150mg Capsule Venlafaxine (as Hydrochloride) 150mg Pfizer Ireland Pharmaceuticals, Kildare, Republic of Ireland

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26 November 2022

POM

648 BRU12110955P Eprex® 4000 Prefilled Syringe 4000IU/0.4ml

Epoetin alfa 4,000IU/0.4ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26 November 2022

POM

649 BRU121109561P Topamax® 50 Tablets Topiramate 50mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26 November 2022

POM

650 BRU12110956NP Vitamin C 100mg Tablet Ascorbic Acid 100mg Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 27 November 2017 till 26 November 2022

GSL

651 BRU12110957PS1; BRU12110957PS2

Actrapid® 100IU/ml Solution for Injection

Insulin Human (rDNA) 100iu/ml Novo Nordisk A/S, Denmark (S1); Novo Nordisk Production SAS, France (S2)

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26 November 2022

POM

652 BRU12110958P Tretinon Cream 0.05% Tretinoin (Retinoic acid) 0.5mg/g Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 27 November 2017 till 26 November 2022

POM

653 BRU12110959P Eprex® 2000 Prefilled Syringe 2000IU/0.5ml

Epoetin alfa 2,000IU/0.5ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26 November 2022

POM

654 BRU12110960NP Daflon 500mg Tablet Diosmin 450mg; Hesperidin 50mg Les Laboratories Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26 November 2022

GSL

655 BRU12110962P Tenol-100 Atenolol 100mg Sunward Pharmaceutical Pte Ltd, Singapore

G & H Trading Company 27 November 2017 till 26 November 2022

POM

656 BRU12110963NP Polysilic III Suspension Per 5ml contains Dried Aluminium Hydroxide Gel 400mg; Magnesium Trisilicate light 400mg; Simethicone 30mg

Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 27 November 2017 till 26 November 2022

GSL

BDMCA/RMP/1220 Page 43 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

657 BRU12110964P Exjade 125mg Dispersible Tablets

Deferasirox 125mg Novartis Pharmas Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26 November 2022

POM

658 BRU12110965P Exjade 500mg Dispersible Tablets

Deferasirox 500mg Novartis Pharmas Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 27 November 2017 till 26 November 2022

POM

659 BRU12120967P CervarixTM Vaccine (Prefilled Syringe)

1 dose (0.5ml) contains: Human Papillomavirus type 16 L1 protein 20mcg; Human Papillomavirus type 18 L1 protein 20mcg; 3-O-desacyl-4'-monophosphoryl lipid A (MPL) 50mcg; adsorbed on aluminium hydroxide, hydrated (Al(OH)3) 0.5mcg Al3+

GlaxoSmithKine Biologicals S.A., Rixensart, Belgium

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

660 BRU12120968NP Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Sodium with 4.25% Dextrose

Per 100ml contains Calcium Chloride 18.3mg; Dextrose hydrous 4.25g; Magnesium Chloride 5.08mg; Sodium Chloride 538mg; Sdoium Lactate 448mg

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 27 December 2017 till 26 December 2022

GSL

661 BRU12120969NP ENO Orange Each 4.3g contains Citric Acid Anhydrous 1.851g; Sodium Bicarbonate Coarse 1.478g; Sodium Bicarbonate Fine 0.492; Sodium Carbonate Anhydrous 0.43g

Sterling Drug (Malaya) Sdn Bhd., Malaysia

Kingston Beverage & Creamery Sdn Bhd

27 December 2017 till 26 December 2022

GSL

662 BRU12120970P Clementin Film Coated Tablet 625mg

Amoxicillin (as Trihydrate) 500mg; Clavulanic Acid (as Potassium Salt) 125mg

Yung Shin Pharmaceutical Ind. Co. Ltd., Taichung, Taiwan

Asterix United (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

663 BRU12120971P Survanta® Beractant Intratracheal Suspension

Beractant (as phospholipids) 25mg/ml AbbVie Inc., USA [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd. Singapore)

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

664 BRU12120973P ZyprexaTM Tablet 10mg Olanzapine 10mg Lilly del Caribe Inc, Puerto Rico, USA & Lilly S.A., Madrid, Spain

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

665 BRU12120974P SutentTM Hard Capsules 12.5mg

Sunitinib 12.5mg (as Malate) Pfizer Italia S.r.l., Ascoli Piceno, Italy

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

666 BRU12120975PS1 ; BRU12120975PS2

Stelara Solution for Injection in pre-filled syringe 45mg/0.5ml

Ustekinumab 45mg/0.5ml Baxter Pharmaceutical Solutions LLC, Blommington, United States (S1);Cilag AG, Hochstrassse 201, 8200 Schaffhausen. Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

BDMCA/RMP/1220 Page 44 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

667 BRU12120976P Viagra 50mg Tablet Sildenafil 50mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

668 BRU12120977P Viagra 100mg Tablet Sildenafil 100mg (as Citrate) Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

669 BRU12120978P Aerrane (Isoflurane USP) Inhalation Liquid

Isoflurane USP 100% Baxter Healthcare Corporation, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

670 BRU12120980NP Potcit Mixture Per 5ml contains Potassium Citrate 1g; Citric acid anhydrous 200mg

Beacons Pharmaceutical Pte Ltd., Singapore

Hongkiat Trading & Company 27 December 2017 till 26 December 2022

P

671 BRU12120981P Garbose Tablet 100mg Acarbose 100mg Y.S.P Industries (M) Sdn Bhd., Selangor Darul Ehsan, Malaysia

Asterix United (B) Sdn Bhd 27 December 2017 till 26 December 2022

POM

672 BRU13010982P KombiglyzeTM XR Tablet 5/1000mg

Saxagliptin HCl 5mg (as anhydrous 5.58mg); Metformin Hydrochloride 1000mg

AstraZeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

673 BRU13010983P KombiglyzeTM XR Tablet 5/500mg

Saxagliptin HCl 5mg (as anhydrous 5.58mg); Metformin Hydrochloride 500mg

AstraZeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

674 BRU13010984P KombiglyzeTM XR Tablet 2.5/1000mg

Saxagliptin HCl 2.5mg (as anhydrous 2.79mg); Metformin Hydrochloride 1000mg

AstraZeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

675 BRU13010985P Zanidip® 20mg Tablet Lercanidipine HCl 20mg Recordati Industria Chimica & Farmaceutica S.p.A., Milan, Italy

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

676 BRU13010987P Pontalon Tablet 500mg Mefenamic Acid 500mg Y.S.P Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

677 BRU13010988P Co-Trimexazole Suspension Per 5ml - Sulphamethoxazole BP 200mg; Trimethoprim 40mg

Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & CO 26 January 2018 till 25 January 2023

POM

678 BRU13010991P Humulin 30/70 Injection 100iu/ml (vial)

Human insulin* 100IU/mL*In the proportion of 30% Soluble Insulin to 70% Isophane Insulin

Eli Lilly and Co., USA Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

679 BRU13010993P FML® Liquifilm Sterile Opthalmic Solution 0.1%

Fluorometholone 0.1%w/v Allergan Pharmaceuticals Ireland, Ireland

Medipharm Sdn Bhd 26 January 2018 till 25 January 2023

POM

680 BRU13010995P Daivonex® Ointment Calcipotriol 50mcg/g (0.005% w/w) LEO Laboratories Ltd (LEO Pharma), Ireland

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

681 BRU13010996P Seretide Evohaler 25/125mcg Per actuation - Fluticasone propionate 125mcg; Salmetarol 25mcg (as xinafoate)

Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

682 BRU13010997P Glucophage® Tablet 850mg Metformin HCl 850mg (~Metformin 662.9mg)

Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

BDMCA/RMP/1220 Page 45 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

683 BRU13010998PS1; BRU13010998PS2

Revlimid®Capsules 5mg Lenalidomide 5mg Penn Pharmaceutical Services Limited, UK (S1) & Celgene International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

684 BRU13010999NP Infusol® NS Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 January 2018 till 25 January 2023

GSL

685 BRU13011005P Zyprexa 5mg Tablet Olanzapine 5mg Lilly del Caribe Inc., Puerto Rico, USA & Lilly, S.A., Spain

Zuellig Pharma (B) Sdn Bhd 26 January 2018 till 25 January 2023

POM

686 BRU13021006P Canesten GYN 6 day 6-Day-Therapy

Clotrimazole 100mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25 February 2023

P

687 BRU13021008P Prevenar 13 Suspension for Injection

Per 0.5ml - Pneumococcal Polysaccharide Serotype 1, 3, 4, 5, 6A, 7F, 9V, 14, 18C, 19A, 19F, 23F - 2.2mcg; Pneumococcal Polysaccharide Serotype 6B - 4.4mcg

Pfizer Ireland Pharmaceuticals, Dublin, Ireland; Pfizer Manufacturing Belgium NV, Belgium (Labelling and secondary packaging site)

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25 February 2023

POM

688 BRU13021009P Hemabate Sterile Solution 250mcg/ml

Carboprost (as tromethamine) 250mcg/ml

Pharmacia & Upjohn Company LLC, USA

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25 February 2023

POM

689 BRU13021011P Extraneal Peritoneal Dialysis Solution 75g/L

Per 100ml: Icodextrin 7.5g; Sodium Chloride 538mg; Sodium Lactate 448mg; Calcium Chloride 25.7mg; Magnesium Chloride 5.08mg

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 26 February 2018 till 25 February 2023

POM

690 BRU13021012P Afinitor Tablet 10mg Everolimus 10mg Novartis Pharma Stein AG, Stein, Switzerland

Medipharm Sdn Bhd 26 February 2018 till 25 February 2023

POM

691 BRU13021013P Ketovid Cream 2% Ketoconazole 2.0% w/w Hovid Bhd, Perak, Malaysia G & H Trading Company 26 February 2018 till 25 February 2023

GSL

692 BRU13021015P Azopt Eye Drops, Suspension Brinzolamide 10mg/ml (1.0%w/w) S.A. Alcon-Couvreur N.V., Belgium

Medipharm Sdn Bhd 26 February 2018 till 25 February 2023

POM

693 BRU13021016P Rhewlin SR Tablet Diclofenac Sodium 100mg Beacons Pharmaceutical Pte Ltd, Singapore

Hongkiat Trading & Co 26 February 2018 till 25 February 2023

POM

694 BRU13021017P Xepa Hydrogen Peroxide Solution 6%

Hydrogen Peroxide 6% w/v (equivalent to 20 volumes of oxygen)

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Co 26 February 2018 till 25 February 2023

GSL

695 BRU13021019P Stilamin 3000 for Injection 3mg/ampoule

Somatostatin (as acetate) 3mg Merck Serono SA, Aubonne, Switzerland

G&H Trading Company 26 February 2018 till 25 February 2023

POM

696 BRU13021020P Loradine Syrup 1mg/ml Loratadine 1mg/ml Y.S.P Industries (M) Sdn Bhd, Selangor Darul Ehsan, Malaysia

Asterix United (B) Sdn Bhd 26 February 2018 till 25 February 2023

P

697 BRU13021021P Decozol Oral Gel 2% w/w Miconazole 2% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 26 February 2018 till 25 February 2023

GSL

698 BRU13021022P Rasitol Injection 20mg/2ml Furosemide 20mg/2ml Yung Shin Pharmaceutical Ind. Co. Ltd., Taiwan, ROC

Asterix United (B) Sdn Bhd 26 February 2018 till 25 February 2023

POM

BDMCA/RMP/1220 Page 46 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

699 BRU13021023P Fusate-250 Tablet Sodium fusidate 250mg Noripharma Sdn Bhd, Selangor Darul Ehsan, Malaysia

K-Seri Pharma Sdn Bhd 26 February 2018 till 25 February 2023

POM

700 BRU13021024P Premarin Vaginal Cream Conjugated Oestrogen (CE) 0.625mg/g PF Consumer Healthcare Canada ULC, Canada

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25 February 2023

POM

701 BRU13021026P Kaletra Film-coated Tablet 200mg/50mg

Lopinavir 200mg; Ritonavir 50mg AbbVie Deutschland GmbH & Co. KG, Germany [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore)

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25 February 2023

POM

702 BRU13021027P Sustanon 250 Per 1ml - Testosterone decanoate 100mg; Testosterone phenylpropionate 60mg; Testosterone isocaproate 60mg; Testosterone propionate 30mg [Equivalent to Testosterone 176mg/ml]

Merck Sharp & Dohme, the Netherlands

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25 February 2023

POM

703 BRU13021028P Holoxan for Injection Ifosfamide 1g Baxter Oncology GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 26 February 2018 till 25 February 2023

POM

704 BRU13031029NP Panadol Extend Tablet Paracetamol 665mg GlaxoSmithKline Consumer Healthcare Australia Pty Ltd., Australia

Kingston Beverage & Creamery Sdn Bhd

28 March 2018 till 27 March 2023

P

705 BRU13031030P Canesten Cream 1% w/w Clotrimazole 1% w/w Encube Ethicals Private Ltd, India Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March 2023

GSL

706 BRU13031035P Hydralazine Tablet 50mg Hydralazine HCl 50mg Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Co 28 March 2018 till 27 March 2023

POM

707 BRU13031037P Tracidol Capsule 50mg Tramadol HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 28 March 2018 till 27 March 2023

POM

708 BRU13031038P Solcoseryl Dental Adhesive Paste

Per g - Solcoseryl CMC 2.125mg; Polidocanol 10mg

Legacy Pharmaceuticals Switzreland GmbH, Switzerland

Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March 2023

POM

709 BRU13031039NP Infusol® S3 Sodium Chloride 3% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 28 March 2018 till 27 March 2023

POM

710 BRU13031040P Intril SR 1.5mg Tablets Indapamide 1.5mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 28 March 2018 till 27 March 2023

POM

711 BRU13031042P Inox Capsule 100mg Itraconazole 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2018 till 27 March 2023

POM

712 BRU13031043P Doxycap capsule 100mg Anhydrous Doxycycline 100mg Hovid Bhd, Malaysia G & H Trading Company 28 March 2018 till 27 March 2023

POM

BDMCA/RMP/1220 Page 47 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

713 BRU13031045P Recormon Pre-filled Syringe 2000IU/0.3ml

Erythropoetin Beta 2,000iu/0.3ml Roche Diagnostics GmbH, Germany (Labeling and Secondary packaging); F. Hoffmann-La Roche AG, Kaiseraugst, Switzerland; Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg , Germany

MediPharm Sdn Bhd 28 March 2018 till 27 March 2023

POM

714 BRU13031046P Leukeran Tablet 2mg Chlorambucil 2mg Excella GmbH & Co. KG., Germany

Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March 2023

POM

715 BRU13031047P Recormon Pre-filled Syringe 4000IU/0.3ml

Erythropoetin Beta 4,000iu/0.3ml Roche Diagnostics GmbH, Germany (Labeling and Secondary packaging); F. Hoffmann-La Roche AG, Kaiseraugst, Switzerland; Vetter Pharma-Fertigung GmbH & Co. KG, Ravensburg , Germany

MediPharm Sdn Bhd 28 March 2018 till 27 March 2023

POM

716 BRU13031050P; BRU13031050PS2; BRU13031050PS3

Isentress 400mg Tablet Raltegravir 400mg (as potassium 434.4mg)

MSD International GmbH (Singapore Branch) 21 Tuas South Avenue 6 Singapore 637766; MSD International GmbH, Ireland (S2); MSD International GmbH (Singapore Branch), 70 Tuas West Drive, Singapore 638414, Singapore (S3)

Zuellig Pharma (B) Sdn Bhd 28 March 2018 till 27 March 2023

POM

717 BRU13041051P Taxotere 80mg/4ml Concentrate for Solution for Infusion

Docetaxel trihydrate 80mg/4ml Sanofi-Aventis Deutschland GmbH, Germany

Medipharm Sdn Bhd 30 April 2018 till 29 April 2023

POM

718 BRU13041052P Fosamax Plus Tablet 70mg/5600IU

Alendronic Acid 70mg (as Sodium 91.37mg); Colecalciferol 140mcg (5,600IU)

Rovi Pharma Industrial Services S.A., Madrid, Spain

Zuellig Pharma (B) Sdn Bhd 30 April 2018 till 29 April 2023

POM

719 BRU13041055P Alpranax Tablet 0.5mg Alprazolam 0.5mg Y.S.P Industries (M) Sdn Bhd Malaysia

K-Seri Pharma Sdn Bhd 30 April 2018 till 29 April 2023

POM

720 BRU13041056NP Liquid Paraffin Liquid Paraffin 100%w/w Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 30 April 2018 till 29 April 2023

GSL

721 BRU13041058P Pegasys Pre-filled Syringe 180mcg/0.5ml

Peginterferon alfa-2a 180mcg/0.5ml F Hoffman-La Roche Ltd, Switzerland; F Hoffman-La Roche Ltd, Betriebsstandort Kaiseraugst (Parenterals), Switzerland

Hongkiat Trading & Co 30 April 2018 till 29 April 2023

POM

BDMCA/RMP/1220 Page 48 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

722 BRU13041059P Borymycin Capsule 50mg Minocycline HCl 50mg Y.S.P Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 April 2018 till 29 April 2023

POM

723 BRU13041060P Kytril Tablet 1mg Granisetron 1mg (as HCl) Delpharm Milano S.r.I., Via Carnevale 1, 20090, Segrate (Milano), Italy

Hongkiat Trading & Co 30 April 2018 till 29 April 2023

POM

724 BRU13041061NP Venofer® Solution for Injection 100mg/5ml

Iron (III) [as Iron (III)-hydroxide sucrose complex] 100mg/5ml

IDT Biologika GmbH, Germany; BIPSO GmbH, Germany; Takeda Austria GmbH, Austria

Hongkiat Trading & Co 30 April 2018 till 29 April 2023

POM

725 BRU13041062NP Calamine cream Calamine 4%w/w; Zinc Oxide 3% w/w Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 30 April 2018 till 29 April 2023

GSL

726 BRU13041063P Apuzin tablet 25mg Captopril 25mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 April 2018 till 29 April 2023

POM

727 BRU13041064P Lezpain film-coated tablet 135mg

Mebeverine HCl 135mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 April 2018 till 29 April 2023

POM

728 BRU13041067NP White Soft Paraffin White Soft Paraffin Sasaol Wax GmbH, Germany [Repacker: Beacons Pharmaceuticals Pte Ltd., 21 Chin Bee Avenue, Singapore]

Hongkiat Trading & Co 30 April 2018 till 29 April 2023

GSL

729 BRU13041068NP Calamine Lotion 15% w/v Calamine 15%w/v Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 30 April 2018 till 29 April 2023

GSL

730 BRU13061069P Votrient™ Film-coated tablets 200mg

Pazopanib (as hydrochloride) 200mg Glaxo Operations UK Ltd, Hertfordshire, UK

Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June 2023

POM

731 BRU13061070PS1; BRU13061070PS2; BRU13061070PS3

NovoMix® 30 FlexPen® Suspension for Injection 100 U/ml

1ml contains 100u of Soluble Insulin aspart 30% and Protamine-crystallised Insulin aspart 70%

Novo Nordisk Producao Farmaceutica do Brasil Ltda., Brazil (S1); Novo Nordisk A/S, Bagsværd, Denmark (S2); Novo Nordisk Production SAS, France (S3)

Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June 2023

POM

732 BRU13061071P Duphaston Tablet 10mg Dydrogesterone 10mg Abbott Biologicals B.V., The Netherlands

Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June 2023

POM

733 BRU13061073P Prednisolone Tablet 20mg Prednisolone 20mg Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 4 June 2018 till 03 June 2023

POM

734 BRU13061074P Kytril For Infusion 3mg/3ml Granisetron 3mg (as HCl 3.36mg) Cenexi SAS, France Hongkiat Trading & Co 04 June 2018 till 03 June 2023

POM

735 BRU13061075P Minison Tablet 1mg Prazosin 1mg (as HCl 1.095mg) Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 04 June 2018 till 03 June 2023

POM

736 BRU13061076P; BRU13061076PS2; BRU13061076PS3

Xeloda™ Tablets 500mg Capecitabine 500mg Productos Roche S.A. de C.V, Mexico; Shanghai Roche Pharmaceuticals Ltd, China (S2); Excella GmbH & Co. KG, Germany (S3)

Hongkiat Trading & Co 04 June 2018 till 03 June 2023

POM

BDMCA/RMP/1220 Page 49 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

737 BRU13061077P Chloramphenicol Eye Ointment

Chloramphenicol 10mg/g KRKA d.d., Slovenia K-Seri Pharma Sdn Bhd 04 June 2013 till 03 June 2018

POM

738 BRU13061078NP Zentel Tablet 200mg Albendazole 200mg Tianjin SKF Labs Ltd, Tianjin, China

Kingston Beverage & Creamery Sdn Bhd

04 June 2018 till 03 June 2023

GSL

739 BRU13061079NP Maltofer® Syrup Iron (III) [as Iron (III)-hydroxide-polymaltose complex] 10mg/ml

Vifor S.A., Switzerland Medipharm Sdn Bhd 04 June 2018 till 03 June 2023

GSL

740 BRU13061080P Noriday® Tablet Norethisterone 0.35mg Piramal Healthcare UK Limited, United Kingdom

Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June 2023

POM

741 BRU13061081P Keppra 250mg Film-coated Tablet

Levetiracetam 250mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June 2023

POM

742 BRU13061082P Keppra 500mg Film-coated Tablet

Levetiracetam 500mg UCB Pharma S.A., Belgium Zuellig Pharma (B) Sdn Bhd 04 June 2018 till 03 June 2023

POM

743 BRU13061083PS3, BRU13061083PS4, BRU13061083PS5

Avastin Concentrate For Solution For Infusion 400mg/16ml

Bevacizumab 400mg/16ml Roche Diagnostics GmbH, Manheim, Germany (S3); F Hoffmann-La Roche Ltd, Kaiseraugst, Switzerland (S4); Genentech Inc., Hillsboro, OR, USA (S5)

Hongkiat Trading & Co 04 June 2018 till 03 June 2023

POM

744 BRU13061084P; BRU13061084PS2

Xeloda Tablet 150mg Capecitabine 150mg Productos Roche S.A. de C.V, Mexico; Excella GmbH & Co. KG, Germany

Hongkiat Trading & Co 04 June 2018 till 03 June 2023

POM

745 BRU13061085P Uripax Film-coated Tablet 200mg

Flavoxate HCl 200mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 04 June 2018 till 03 June 2023

POM

746 BRU13061087P Elonva Solution for Injection 150mcg/0.5ml

Corifollitrophin alfa 150mcg/0.5ml Vetter Pharma-Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 27 June 2018 till 26 June 2023

POM

747 BRU13061088P Maxitrol Eye Ointment Per g: Neomycin Sulfate 3,500 IU; Polymyxin B Sulfate 6,000IU; Dexamethasone 0.1%

S.A. Alcon-Couvreur N.V., Belgium

Medipharm Sdn Bhd 27 June 2018 till 26 June 2023

POM

748 BRU13061090NP Ciproxol (Ciprofloxacin) 0.2% w/v Intravenous Infusion BP

Ciprofloxacin 0.2% w/v Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2018 till 26 June 2023

POM

749 BRU13061091NP Infusol® W Intravenous Infusion BP

Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 June 2018 till 26 June 2023

GSL

750 BRU13061092P Isoket Ampoule 10mg/10ml Isosorbide Dinitrate 10mg/10ml (0.1%) EVER Pharma Jena GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 27 June 2018 till 26 June 2023

POM

751 BRU13061094P Pharmaniaga Simvastatin tablet 10mg

Simvastatin 10mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 27 June 2018 till 26 June 2023

POM

752 BRU13061095P Vitamin B1 Tablet Thiamine HCl 10mg Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 27 June 2018 till 26 June 2023

POM

753 BRU13071099P Champix 1mg film-coated tablet

Varenicline Tartrate 1mg Pfizer Manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023

POM

BDMCA/RMP/1220 Page 50 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

754 BRU13071100P Iodosorb Ointment Cardexomar Iodine (eq. to Iodine 0.9%) Perstorp Speciality Chemicals, Sweden

Mc Quipp Technisell Marketing Sdn Bhd

30 July 2018 till 29 July 2023

P

755 BRU13071101P Glucophage XR 500mg Extended Release Tablet

Metformin HCl 500mg Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023

POM

756 BRU13071102P Victrelis Capsule 200mg Boceprevir 200mg Schering-Plough (Singapore) Pte Ltd, Singapore

Zuellig Pharma (B) Sdn Bhd 30 July 2013 till 29 July 2018

POM

757 BRU13071103P Axcel Cefaclor-250 Capsule Cefaclor (as monohydrate) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 July 2018 till 29 July 2023

POM

758 BRU13071104P Gonal-F Powder and Solvent for Solution for Injection 75IU (5.5mcg)/ vial

Follitrophin Alfa 75 IU ( 5.5mcg) Merck Serono S.p.A., Bari (MSB), Italy; Merck Serono S.A. (MSA), Swizerland

G & H Trading Company 30 July 2018 till 29 July 2023

POM

759 BRU13071108PS1; BRU13071108PS2

Revlimid® Capsules 25mg Lenalidomide 25mg Penn Pharmaceutical Services Limited, UK (S1) & Celgene International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023

POM

760 BRU13071109PS1; BRU13071109PS2

Revlimid® Capsules 15mg Lenalidomide 15mg Penn Pharmaceutical Services Limited, UK (S1) & Celgene International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023

POM

761 BRU13071110P Solcoseryl Eye Gel Solcoseryl 120 Concentrate 8.3mg/g Legacy Pharmaceuticals Switzreland GmbH, Switzerland

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023

POM

762 BRU13071111P Micosten-H Cream Miconazole Nitrate 2%; Hydrocortisone 1%

Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 30 July 2018 till 29 July 2023

P

763 BRU13071114P Sandimmun Neoral Capsule 25mg

Ciclosporin A 25mg Catalent Germany Eberbach GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 30 July 2018 till 29 July 2023

POM

764 BRU13081115P Champix 0.5mg & 1mg Tablet Varenicline Tartrate 0.5mg & Varenicline Tartrate 1mg

Pfizer Manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26 August 2023

POM

765 BRU13081116P Daktarin Oral Gel 2% Miconzaole 2% Janssen Pharmaceutical NV, Belgium

Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26 August 2023

P

766 BRU13081120P Enbrel® 25mg solution for injection in pre-filled syringe

Etanercept 25mg/0.5ml Pfizer Ireland Pharmaceuticals, Ireland

Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26 August 2023

POM

767 BRU13081122P Requip® Tablet 1mg Ropinirole (as Hydrochloride) 1mg Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 August 2018 till 26 August 2023

POM

768 BRU13081123P Minazol Powder 2% Miconazole Nitrate 2% w/w Chulia Pharma Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 27 August 2018 till 26 August 2023

P

769 BRU13081124P Heparinol 5000IU/ml Heparin Sodium (bovine) 5,000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 27 August 2018 till 26 August 2023

POM

770 BRU13081125P Pharmaniaga Pyrazinamide Tablet 500mg

Pyrazinamide 500mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 27 August 2018 till 26 August 2023

POM

BDMCA/RMP/1220 Page 51 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

771 BRU13081127P Ketovid Shampoo 2% w/v Ketoconazole (micronised) 2% w/w Hovid Bhd, Malaysia G & H Trading Company 27 August 2018 till 26 August 2023

GSL

772 BRU13081128P Maxitrol Eye Drops Per 1ml - Dexamethasone 0.1%; Neomycin Sulphate 3,500IU; Polymyxin B Sulphate 6,000 IU

S.A. Alcon-Couvreur N.V., Belgium

Medipharm Sdn Bhd 27 August 2018 till 26 August 2023

POM

773 BRU13091130P Erbitux® 5mg/ml Solution for Infusion

Cetuximab 5mg/ml Boehringer Ingelheim, Germany & Merck Healthcare KGaA, Germany (1 Artwork)

Zuellig Pharma (B) Sdn Bhd 28 September 2018 till 27 September 2023

POM

774 BRU13091132NP Beafort Syrup Each 5ml contains: Thiamine HCl 5mg; Riboflavin 2.5mg; Pyridoxine HCl 2mg; Cyanocobalamin 5mcg; Nicotinamide 20mg; Calcium Panthothenate 1.5mg

Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 28 September 2018 till 27 September 2023

GSL

775 BRU13091133P Clexane 4000/0.4ml Anti XA Pre-filled Syringe

Enoxaprin sodium 4,000 anti-Xa IU/0.4ml equivalent to 40mg/0.4ml

Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 28 September 2018 till 27 September 2023

POM

776 BRU13091135P Iodosorb Powder Cadexomer 99.1% w/w, with Iodine 0.9%w/w

Perstorp Speciality Chemicals AB, Sweden

Mc Quipp Technisell Marketing Sdn Bhd

28 September 2018 till 27 September 2023

P

777 BRU13091136P Anlodin Tablet 10mg Amlodipine (as besylate) 10mg Y.S.P Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 28 September 2018 till 27 September 2023

POM

778 BRU13091138P Clexane 6000/0.6ml Anti-Xa IU Pre-filled Syringe

Enoxaprin sodium 6,000 anti-Xa IU/0.6ml equivalent to 60mg/0.6ml

Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 28 September 2018 till 27 September 2023

POM

779 BRU13091140P Camazol Tablet 5mg Carbimazole 5mg Xepa-Soul Pattinson (M) Sdn Bhd Malaysia

Hongkiat Trading & Co 28 September 2018 till 27 September 2023

POM

780 BRU13091141P Pulin Injection 10mg/2ml Metoclopramide HCl 10mg/2ml Yung Shin Pharmaceutical Ind. Co. Ltd., Taiwan

Asterix United (B) Sdn Bhd 28 September 2018 till 27 September 2023

POM

781 BRU13091142NP Sulbutiamine 200 capsule Sulbutiamine 200mg Pahang Pharmacy Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 28 September 2018 till 27 September 2023

GSL

782 BRU13091143P VelcadeTM 3.5mg for Injection Bortezomib 3.5mg Pierre Fabree Medicament Productio (PFMP), France & BSP Pharmaceuticals S.p.A. (BSP), Latina, Italy - (1 artwork)

Zuellig Pharma (B) Sdn Bhd 28 September 2018 till 27 September 2023

POM

783 BRU13091144P Bezamidin Tablet 200mg Bezafibrate 200mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn Bhd 28 September 2018 till 27 September 2023

POM

784 BRU13091145NP A-Bite Cream Crotamiton 10%w/w HOE Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 28 September 2018 till 27 September 2023

GSL

785 BRU13101149P Erycin Film Coated Tablet 250mg

Erythromycin (as stearate) 250mg Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 31 October 2018 till 30 October 2023

POM

BDMCA/RMP/1220 Page 52 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

786 BRU13101151NP ENO Fruit Salt Lemon Per 4.3g - Sodium Bicarbonate Coarse 1.468g (34.16%w/w); Sodium Bicarbonate Fine 0.489g (11.39%w/w); Citric Acid Anhydrous 1.853g (43.10%w/w); Sodium Carbonate Anhydrous 0.43g (10.0%w/w)

Sterling Drug (Malaya) Sdn Bhd, Malaysia

Kingston Beverage & Creamery Sdn Bhd

31 October 2018 till 30 October 2023

GSL

787 BRU13101152P Hycamtin™ Injection 1MG Topotecan (as HCl) 1mg GlaxoSmithKline Manufacturing S.p.A., Parma, Italy

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30 October 2023

POM

788 BRU13101153P Clexane 2000 anti-Xa IU/0.2ml (Pre-filled Syringe for Injection)

Enoxaparin Sodium 2,000 anti-Xa IU/0.2ml

Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 31 October 2018 till 30 October 2023

POM

789 BRU13101154P Axcel Mefenamic Acid Suspension

Mefenamic Acid 125mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 31 October 2018 till 30 October 2023

POM

790 BRU13101155P Ovidrel Solution for Injection 250mcg/0.5ml in Pre-filled Syringe

Choriogonadotropin alfa 250mcg/0.5ml Merck Serono S.p.A., Italy & Merck Serono S.A., Switzerland

G & H Trading Company 31 October 2018 till 30 October 2023

POM

791 BRU13101156P Sandimmun Neoral Capsule 100mg

Ciclosporin 100mg Catalent Germany Eberbach GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30 October 2023

POM

792 BRU13101158P Endoxan Tablet 50mg Cyclophosphamide anhydrous (as monohydrate) 50mg

Prasfarma S.L., Manlleu/Barcelona, Spain; Haupt Pharma Amareg GmBH, Germany

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30 October 2023

POM

793 BRU13101159P CEF-4® Injection 500mg Ceftazidime (as pentahydrate) 500mg Siam Bheasach Co. Ltd., Bangkok, Thailand

K-Seri Pharma Sdn Bhd 31 October 2018 till 30 October 2023

POM

794 BRU13101160P Premarin Tablet 0.625mg Conjugated Estrogens 0.625mg Pfizer Ireland Pharmaceuticals, Kildare, Ireland

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30 October 2023

POM

795 BRU13101161PS1; BRU13101161PS2

Revlimid® Capsules 10mg Lenalidomide 10mg Penn Pharmaceutical Services Limited, UK (S1) & Celgene International Sarl, Switzerland (S2)

Zuellig Pharma (B) Sdn Bhd 31 October 2018 till 30 October 2023

POM

796 BRU13101162P Pharmaniaga Cephalexin Suspension 125mg

Cephalexin (as anhydrous) 125mg/5ml Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 31 October 2018 till 30 October 2023

POM

797 BRU13121167P Copastin Film Coated Tablets 10mg

Cloperastine Hydrochloride 10mg Y.S.P Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 02 December 2018 till 01 December 2023

P

798 BRU13121168P Ucort Cream Per g – Urea 100mg; Hydrocortisone acetate 10mg

Y.S.P Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 02 December 2018 till 01 December 2023

P

799 BRU13121169P Pradaxa® Hard Capsules 150mg

Dabigatran etexilate 150mg (as mesilate 172.95g)

Boehringer Ingelheim Pharma GmbH &Co, Ingelheim am Rhein, Germany

Hongkiat Trading & Co 02 December 2018 till 01 December 2023

POM

BDMCA/RMP/1220 Page 53 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

800 BRU13121170P Pradaxa® Hard Capsules 110mg

Dabigatran etexilate 110mg (as mesilate 126.83g)

Boehringer Ingelheim Pharma GmbH & Co., KG, Germany

Hongkiat Trading & Co 02 December 2018 till 01 December 2023

POM

801 BRU13121172NP Dianeal Low Calcium (2.5mEq/L) Peritoneal Dialysis Solution with 1.5% Dextrose

Each 100ml contains: Calcium Choloride 18.3mg; Dextrose hydrous 1.5g; Magnesium Chloride 5.08mg; Sodium Chloride 538mg; Sodium Lactate 448mg

Baxter Healthcare SA, Singapore Medipharm Sdn Bhd 02 December 2018 till 01 December 2023

GSL

802 BRU13121174P Temodal Capsules 100mg Temozolomide 100mg Orion Corporation, Finland Zuellig Pharma (B) Sdn Bhd 02 December 2018 till 01 December 2023

POM

803 BRU13121177P Cyclogyl® 1% Sterile Ophthalmic Solution

Cyclopentolate Hydrochloride 1% S.A. Alcon-Couvreur N.V., Belgium

Hongkiat Trading & Co 02 December 2018 till 01 December 2023

POM

804 BRU13121178P Betawin Tablet 50mg Metoprolol Tartrate 50mg Duopharma (M) Sdn Bhd Malaysia

Hongkiat Trading & Co 02 December 2018 till 01 December 2023

POM

805 BRU13121179P Imigran FD Tablets 50mg Sumatriptan 50mg ( as succinate) Glaxo Operations UK Ltd, UK Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29 December 2023

POM

806 BRU13121180P Glucovance Tablet 500mg/5mg

Metformin HCl 500mg; Glibenclamide 5mg

Merck Sante SAS, France Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29 December 2023

POM

807 BRU13121182P Hycamtin Injection 4mg Topotecan (as Hydrochloride) 4mg GlaxoSmithKline Manufacturing S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 30 December 2018 till 29 December 2023

POM

808 BRU13121183P Anarex Tablets Paracetamol 450mg; Orphenadrine citrate 35mg

Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 30 December 2018 till 29 December 2023

P

809 BRU13121187NP 10% Glucose Intravenous Infusion B.P.

Glucose monohydrate (as equiv. to anhydrous glucose) 10%

B Braun Industries Sdn Bhd, Malaysia

Hongkiat Trading & Co 30 December 2018 till 29 December 2023

POM

810 BRU13121189P Heparinised Saline Injection 10iu/ml (5ml)

Heparin Sodium (Bovine Mucosa) 10i.u./ml

B Braun Medical Industries Sdn Bhd, Malaysia

Hongkiat Trading & Co 30 December 2018 till 29 December 2023

POM

811 BRU13121192NP Nutriflex Lipid Peri Emulsion for Infusion

1 unit consists of Amino Acid Solution; Glucose Solution; Lipid Emulsion

B Braun Industries Sdn Bhd, Malaysia

Hongkiat Trading & Co 30 December 2018 till 29 December 2023

POM

812 BRU14011193PS1 Alimta 500mg Powder for Solution for Infusion

Pemetrexed (as Pemetrexed disodium) 500mg/vial

Eli Lilly and Company, USA (S1) Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27 January 2024

POM

813 BRU14011196P Largo Tablets 100mg Chlorpromazine HCl 100mg Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 28 January 2019 till 27 January 2024

POM

814 BRU14011197NP Axcel Eviline Forte Suspension Each 5ml contains: Magnesium Hydroxide 400mg, Aluminium Hydroxide 400mg and Simethicone 40mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd, Malaysia 28 January 2019 till 27 January 2024

GSL

815 BRU14011198NP Bepanthen® First Aid Cream Dexpanthenol 5%w/w; Chlorhexidine hydrochloride 0.5% w/w

GP Grenzach Produktions GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27 January 2024

GSL

BDMCA/RMP/1220 Page 54 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

816 BRU14011199NP; BRU14011199NPS2

Dextrose 5% and Sodium Chloride 0.9% Injection USP

Dextrose 5%; Sodium Chloride 0.9% Baxter Healthcare Corporation, North Carolina , USA; Baxter Healthcare Philippines, Inc., Laguna, Philippines (S2)

Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27 January 2024

GSL

817 BRU14011200NP Macgel® Tablet Magnesium Hydroxide 200mg; Aluminium Hydroxide Gel Dried 200mg; Dimethylpolysiloxane 25mg

Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 28 January 2019 till 27 January 2024

GSL

818 BRU14011203P Betaserc 24mg Tablet Betahistine dihydrochloride 24mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27 January 2024

POM

819 BRU14011204P Humalog Mix50 100 units/ml Kwikpen

Insulin Lispro * 100U/ml (equivalent to 3.5mg) * in the proportion of 50% insulin lispro solution and 50% insulin lispro protamine suspension (rDNA origin)

Lilly France S.A.S., France (repacker - Eli Lilly And Company, USA)

Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27 January 2024

POM

820 BRU14011205NP Panamol Tablet 500mg Paracetamol 500mg Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 28 January 2019 till 27 January 2024

P

821 BRU14011206P Seretide™ Evohaler™ 25/50mcg

Fluticasone propionate 50mcg; Salmeterol (as xinafoate) 25mcg

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27 January 2024

POM

822 BRU14011207PS1 Tobrex® Eye Drops Solution Tobramycin 0.3% (3mg/ml) S.A. Alcon-Couvreur N.V., Belgium (S1)

Medipharm Sdn Bhd 28 January 2019 till 27 January 2024

POM

823 BRU14011208P PNEUMOVAX 23 Pneumococcal Polysaccharide Danish Types 1,2,3,4,5,6B, 7F,8,9N,9V, 10A, 11A, 12F, 14, 15B, 17F, 18C, 19A, 19F, 20, 22F, 23F, 33F. Each 0.5ml dose contains 25µg of each polysaccharide type

Merck Sharp & Dohme Corp, USA

Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27 January 2024

POM

824 BRU14011209P NEUPOGEN PRE-FILLED SYRINGE 30MU/0.5ML

Filgrastim 30mu/0.5ml Amgen manufacturing Limited (AML), Puerto Rico, United States

Medipharm Sdn Bhd 28 January 2019 till 27 January 2024

POM

825 BRU14011211NPS1; BRU14011211NPS2

Tears Naturale II Eye Drops Solution

Dextran 70 0.1% (1mg/ml); Hypromellose 0.3% (3mg/ml)

S.A. Alcon-Couvreur N.V., Belgium (S1); Alcon Singapore Manufacturing Pte Ltd, Singapore (S2)

Hongkiat Trading & Company 28 January 2019 till 27 January 2024

GSL

826 BRU14011212P Axcel Chlorpheniramine-4 Syrup

Chlorpheniramine Maleate 4mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd, Malaysia 28 January 2019 till 27 January 2024

P

BDMCA/RMP/1220 Page 55 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

827 BRU14011213P Imojev Japanese Encephalitis vaccine (live, attenuated) MD

Live, attenuated, recombinant Japanese Encephalitis virus 4.0 - 5.8 log PFU*/dose (0.5ml) *Plaque Forming Unit

Government Pharmaceutical Organization - Meriux Biological Products Co., Ltd., Thailand

Zuellig Pharma (B) Sdn Bhd 28 January 2019 till 27 January 2024

POM

828 BRU14021215P Havrix 1440 Vaccine Inactivated Hepatitis A virus antigen (HAV), HM175 strain 1440 ELISA Units (EL.U.)/ml

GlaxoSmithKline Biologicals SA, Rixensart Belgium (Manufacturer of finished products); GlaxoSmithKline Biologicals S.A., Wavre Belgium (Additional facility for formulation and filling in vials and syringes, Labelling and packaging); GlaxoSmithKline Biologicals Saint Amand Les Eaux, France (Labelling and packaging for vials and syringes; GlaxoSmithKline Biologicals, Dresden, Germany (Filling in syringes)

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

829 BRU14021216P Co-Plavix® 75/100 film-coated tablets

Clopidogrel (as hydrogen sulphate) 75mg; Acetylsalicylic acid 100mg

Sanofi Winthrop Industrie, France

Medipharm Sdn Bhd 27 February 2019 till 26 February 2024

POM

830 BRU14021217P VotrientTM Film-coated tablets 400mg

Pazopanib (as hydrochloride) 400mg Glaxo Operations UK Limited, UK Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

831 BRU14021218P Motilium tablets 10mg Domperidone 10mg Janssen-Cilag, Val de Reuil, France

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

832 BRU14021219PS1; BRU14021219PS2; BRU14021219PS3

Novorapid® Flexpen® 100IU/ml

1ml of solution contains 100U insulin aspart (r-DNA) (equivalent to 3.5mg)

Novo Nordisk Producao Farmaceutica do Brasil Ltda., Brazil (S1); Novo Nordisk A/S, Denmark (S2); Novo Nordisk Production SAS, France (S3)

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

833 BRU14021220P Omelon Enteric Microencapsulated capsule 20mg

Omeprazole 20mg Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

834 BRU14021223P Invega® Sustenna Prolonged Release Suspension for Intramuscular Injection 50mg/0.5ml

0.5ml of solution contains Paliperidone (as palmitate 78mg) 50mg

Janssen Pharmaceutica NV, Belgium

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

BDMCA/RMP/1220 Page 56 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

835 BRU14021224P Invega® Sustenna Prolonged Release Suspension for Intramuscular Injection 75mg/0.75ml

0.75ml of solution contains Paliperidone (as palmitate 117mg) 75mg

Janssen Pharmaceutica NV, Belgium

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

836 BRU14021225P Invega® Sustenna Prolonged Release Suspension for Intramuscular Injection 100mg/1.0ml

1.0ml of solution contains Paliperidone (as palmitate 156mg) 100mg

Janssen Pharmaceutica NV, Belgium

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

837 BRU14021229P NovoSeven® Powder and Solvent for Solution for Injection 2mg

Eptacog Alfa (Activated) 2mg/vial (corresponds to 100 KIU/vial), 1mg/ml after reconstitution.

1 KIU equals 1000 IU (International Units) eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of approximately 50,000 Dalton produced in baby hamster kidney cells (BHK Cells) by recombinant DNA technology.

Novo Nordisk A/S, Gentofte, Denmark; Novo Nordisk A/S, Kalundborg, Denmark

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

838 BRU14021230NP Axcel Eviline Tablet Aluminium Hydroxide 200mg, Magnesium Hydroxide 200mg, Simethicone 20mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26 February 2024

GSL

839 BRU14021231P Axcel Loratadine syrup Loratadine 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26 February 2024

P

840 BRU14021232P Cymbalta Capsule 30mg Duloxetine (as hydrochloride) 30mg Lilly del Caribe, Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

841 BRU14021233P TykerbTM tablets 250mg Lapatinib 250mg (as ditosylate monohydrate)

Glaxo Operations UK Limited(Trading as Glaxo Wellcome Operations), UK [Repacker: Glaxo Wellcome S.A., Burgos, Spain

Medipharm Sdn Bhd 27 February 2019 till 26 February 2024

POM

842 BRU14021234P Axcel Mefenamic Acid Capsules

Mefenamic acid 250mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26 February 2024

POM

843 BRU14021235P Dostinex tablet 0.5mg Cabergoline 0.5mg Pfizer Italia S.r.I, Italy Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

BDMCA/RMP/1220 Page 57 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

844 BRU14021236NP; BRU14021236NPS2

Lactated Ringer’s Injection USP

Sodium Chloride 6g/L; Sodium Lactate 3.1g/L; Potassium Chloride 0.3g/L; Calcium Chloride 0.2g/L

Baxter Healthcare Corporation, USA; Baxter Healthcare Philippines Inc., Laguna, Philippines (S2)

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

GSL

845 BRU14021237P Imuran 50mg tablet Azathioprine 50mg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

846 BRU14021238NP Axcel Dicyclomine-S Syrup Per 5mL: Dicyclomine hydrochloride 5mg and Simethicone 50mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26 February 2024

GSL

847 BRU14021239P Humulin R Injection 100IU/ml Regular Human Insulin (Recombinant DNA) 100IU/ml

Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

848 BRU14021240NP 5% Dextrose and 0.45% Sodium Chloride Injection, USP

Dextrose 5%; Sodium Chloride 0.45% Baxter Healthcare Corporation, USA

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

GSL

849 BRU14021241P Giona Easyhaler 200mcg/dose Inhalation Powder

Budesonide 200mcg Orion Corporation, Finland Hongkiat Trading & Co 27 February 2019 till 26 February 2024

POM

850 BRU14021242P Amoxicillin Capsule 500mg Amoxicillin Trihydrate 500mg Yung Shin Pharmaceutical Ind. Co., Taiwan

Asterix United (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

851 BRU14021243NP Neurobion tablet Thiamine disulfide 100mg; Pyridoxine hydroxide 200mg & Cyanocobalamin 200mcg

Merck KGaA & Co, Austria Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

GSL

852 BRU14021244P Omeprazole for Injection (Lyophilised) 40mg/vial

Omeprazole 40mg/vial Gland Pharma Limited, India K-Seri Pharma Sdn Bhd 27 February 2019 till 26 February 2024

POM

853 BRU14021245P Keppra Concentrate for solution for (infusion) / intravenous

Levetiracetam 500mg/5ml Patheon Italia S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

854 BRU14021246P Imojev Japanese Encephalitis Vaccine (live, attenuated)

Live, attenuated, recombinant Japanese Encephalitis virus 4.0 - 5.8 log PFU*/ dose (0.5ml) * Plaque Forming Unit

Government Pharmaceutical organization-Meriux Biological Products Co., Ltd., Thailand

Zuellig Pharma (B) Sdn Bhd 27 February 2019 till 26 February 2024

POM

855 BRU14021247P Pradaxa® Hard Capsules 75mg Dabigatran etexilate 75mg (as mesilate 86.48mg)

Boehringer Ingelheim Pharma GmbH & Co., KG, Germany

Hongkiat Trading & Co 27 February 2019 till 26 February 2024

POM

856 BRU14021248P Axcel Flemin Expectorant Diphenhydramine HCl 12.5mg/5ml; Ammonium Chloride 130mg/5ml

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 27 February 2019 till 26 February 2024

POM

857 BRU14031249P Tygacil 50mg Lyophilised Powder for Intravenous Infusion

Tigecycline 50mg Wyeth Lederle S.r.L, Italy Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

BDMCA/RMP/1220 Page 58 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

858 BRU14031250PS1;BRU14031250PS2 BRU14031250PS3

Levemir Flexpen 100IU/ml Insulin Detemir 100U/ml (equivalent to 14.2mg

Novo Nordisk A/S, Bagsværd, Denmark (S1); Novo Nordisk Producao Farmaceutica do Brasil Ltda., Brazil (S2); Novo Nordisk Production SAS, France (S3)

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

859 BRU14031253P Humulin N Injection 100IU/mL Insulin (Human) Isophane 100iu/ml Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

860 BRU14031256P Gonal-F 300IU/0.5ml solution for injection in a pre-filled pen

Each pen (0.5ml) contains 300IU follitropin alfa (eq. to 22 micrograms)

Merck Serono S.p.A, Italy G&H Trading Company 27 March 2019 till 26 March 2024

POM

861 BRU14031257P Gonal-F 900IU/1.5ml Solution for Injection in a pre-filled pen

Each pen (1.5ml) contains 900IU follitropin alfa (eq. to 66 micrograms). Each ml of solution contains 600IU follitropin alfa (equivalent to 44 micrograms)

Merck Serono S.p.A, Italy G&H Trading Company 27 March 2019 till 26 March 2024

POM

862 BRU14031258P Volibris 5mg Film-coated Tablet

Ambrisentan 5mg Patheon Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

863 BRU14031259P Volibris 10mg Film-coated Tablet

Ambrisentan 10mg Patheon Inc., Ontario, Canada Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

864 BRU14031261P Prograf Capsule 1mg Tacrolimus 1mg Astellas Ireland Ltd, Ireland MediPharm Sdn Bhd 27 March 2019 till 26 March 2024

POM

865 BRU14031263P Patanol 0.1% Olopatadine Hydrochloride Sterile Ophthalmic Solution

Olopatadine (as HCl) 0.1% S.A. Alcon-Couvreur N.V., Belgium

MediPharm Sdn Bhd 27 March 2019 till 26 March 2024

POM

866 BRU14031264PS1 Travatan® Eye Drops 40mcg/ml

Travoprost 40mcg/ml S.A. Alcon-Couvreur N.V., Belgium (S1)

MediPharm Sdn Bhd 27 March 2019 till 26 March 2024

POM

867 BRU14031267P Motilium Suspension 1mg/ml Domperidone 1mg/ml Janssen Pharmaceutica NV, Belgium

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

868 BRU14031268P Elonva Solution for Injection 100mcg/0.5ml

Corifollitropin alfa 100mcg/0.5ml Vetter Pharma-Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

BDMCA/RMP/1220 Page 59 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

869 BRU14031269P Menveo Powder & Solution for Solution for Injection

One dose (0.5ml of the reconstituted vaccine) contains: Originally contained in the powder: Meninggococcal group A oligosaccharide 10micrograms(Conjugated to Corynebacterium diphtheria CRM197 protein 16.7 to 33.3 micrograms)Originally contained in the solution: Meninggococcal group C oligosaccharide 5micrograms(Conjugated to Corynebacterium diphtheria CRM197 protein…..7.1 to 12.5 micrograms); Meninggococcal group W135 oligosaccharide 5micrograms(Conjugated to Corynebacterium diphtheria CRM197 protein 3.3 to 8.3 micrograms); Meninggococcal group Y oligosaccharide 5micrograms(Conjugated to Corynebacterium diphtheria CRM197 protein….5.6 to 10.0. micrograms)

Novartis Vaccines and Diagnostics GmbH, Germany; Novartis Vaccines and Diagnostics S.r.I, Italy

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

870 BRU14031270P Enbrel® 50mg solution for Injection in a pre-filled syringe

Etanercept 50.0mg/1.0ml Pfizer Ireland Pharmaceuticals, Ireland

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

871 BRU14031272P Seretide Evohaler dose-counter 25/250mcg

Salmeterol 25mcg (as the xinafoate) and Fluticasone Propionate 250mcg

Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

872 BRU14031273PS1; BRU14031273PS2

Galvus Met 50/500mg Film-coated Tablet

Vildagliptin 50mg; Metformin HCl 500mg(corresponding to 390mg Metformin)

Novartis Pharma Stein AG, Switzerland (S1); Novartis Pharma Produktions GmbH, Germany (S2)

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

873 BRU14031274PS1; BRU14031274PS2

Galvus Met 50/1000mg Film-coated Tablet

Vildagliptin 50mg; Metformin HCl 1000mg(corresponding to 780mg Metformin)

Novartis Pharma Stein AG, Switzerland (S1); Novartis Pharma Produktions GmbH, Germany (S2)

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

874 BRU14031275PS1; BRU14031275PS2

Galvus Met 50/850mg Film-coated Tablet

Vildagliptin 50mg; Metformin HCl 850mg(corresponding to 660mg Metformin)

Novartis Pharma Stein AG, Switzerland (S1); Novartis Pharma Produktions GmbH, Germany (S2)

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

BDMCA/RMP/1220 Page 60 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

875 BRU14031276P Galvus 50mg Tablet Vildagliptin 50mg Novartis Farmaceutica SA, Spain Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

876 BRU14031279NP Axcel Paracetamol-250 Suspension (Orange)

Paracetamol 250mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 27 March 2019 till 26 March 2024

GSL (60 mL & 100 mL)

877 BRU14031280P Lamictal Dispersible/Chewable Tablet 25mg

Lamotrigine 25mg GlaxoSmithKline Pharmaceutical SA, Poland

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

878 BRU14031281P Panaco Tablets Paracetamol 500mg; Codeine Phosphate 9mg

Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 27 March 2019 till 26 March 2024

POM

879 BRU14031282P Voren Injection ‘Yung Shin’ (Diclofenac)

Diclofenac Sodium 75mg/3ml Yung Shin Pharmaceutical Ind, Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

880 BRU14031284P Xalatan Eyedrops Latanoprost 0.005% w/v Pfizer Manufacturing Belgium NV, Belgium

Zuellig Pharma (B) Sdn Bhd 27 March 2019 till 26 March 2024

POM

881 BRU14041285P Giona Easyhaler® 100mcg/dose Inhalation Powder

Budesonide 100mcg/dose Orion Corporation, Finland Hongkiat Trading & Company 26 April 2019 till 25 April 2024

POM

882 BRU14041286P Axcel Nasatab Tablet Paracetamol 500mg; Chlorpheniramine Maleate 4mg; Pseudoephedrine HCl 60mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 26 April 2019 till 25 April 2024

P

883 BRU14041287P XareltoTM Film-coated tablet 15mg

Rivaroxaban 15mg Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

POM

884 BRU14041288P XareltoTM Film-coated tablet 20mg

Rivaroxaban 20mg Bayer AG, Germany Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

POM

885 BRU14041291NP Sodium Chloride Injection USP 0.9% in Mini-Bag Plus Container

Sodium Chloride 0.9% Baxter Healthcare Corporation, Puerto Rico, USA; Baxter Healthcare, Aibonito, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

GSL

886 BRU14041293P Endoxan® Injection 200mg/vial Cyclophosphamide monohydrate 213.8mg (eq. to anhydrous Cyclophosphamide 200mg)

Baxter Oncology GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

POM

887 BRU14041294P Certican Tablet 0.25mg Everolimus 0.25mg Novartis Pharma Stein, AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

POM

888 BRU14041295P Certican Tablet 0.75mg Everolimus 0.75mg Novartis Pharma Stein, AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

POM

889 BRU14041296P Shincort IM Injection “Yung Shin” 5ml vial

Triamcinolone acetonide 40mg/ml Yung Shin Pharmaceutical Ind. Co. Ltd., Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 26 April 2019 till 25 April 2024

POM

890 BRU14041297PS1 DuoTrav Eye Drops, Solution Travoprost 40mcg/ml; Timolol 5mg/ml (as timolol maleate)

S.A. Alcon-Couvreur N.V., Belgium (S1)

Medipharm Sdn Bhd 26 April 2019 till 25 April 2024

POM

891 BRU14041302P Tasigna Capsule 150mg Nilotinib (as hydrochloride, monohydrate) 150mg

Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

POM

892 BRU14041303P Tasigna Capsule 200mg Nilotinib (as hydrochloride, monohydrate) 200mg

Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

POM

BDMCA/RMP/1220 Page 61 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

893 BRU14041304NP Infusol NSD5 Sodium Chloride 9g/L; Dextrose anhydrous 50g/L

Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2019 till 25 April 2024

POM

894 BRU14041305NP Lactul Solution 670mg/ml Lactulose 670mg/ml Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 26 April 2019 till 25 April 2024

GSL

895 BRU14041306P Kytril for Infusion 1mg/ml Granisetron 1mg (equivalent to Granisetron hydrochloride 1.12mg)

Cenexi SAS, France Hongkiat Trading & Company 26 April 2019 till 25 April 2024

POM

896 BRU14041307P Alimta 100mg Powder for Solution for Infusion

Pemetrexed (as Pemetrexed disodium) 100mg/vial

Eli Lilly and Company, USA Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

POM

897 BRU14041309NP RinsCap W (Sterile Water for Injection BP)

Water for Injection BP Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 26 April 2019 till 25 April 2024

GSL

898 BRU14041313P YSP Ibuprofen Suspension 20mg/ml

Ibuprofen 20mg/ml Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 26 April 2019 till 25 April 2024

P

899 BRU14041314NP; BRU14041314NPS2

Sodium Chloride Injection 0.9%, USP

Sodium Chloride 0.9% Baxter Healthcare Corporation, USA; Baxter Healthcare Philippines Inc., Laguna, Phillippines (S2)

Zuellig Pharma (B) Sdn Bhd 26 April 2019 till 25 April 2024

GSL

900 BRU14041315P Rivadem 3mg Capsule Rivastigmine (as hydrogen tartrate) 3mg

Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 26 April 2019 till 25 April 2024

POM

901 BRU14041316P Rivadem 1.5mg Capsule Rivastigmine (as hydrogen tartrate) 1.5mg

Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 26 April 2019 till 25 April 2024

POM

902 BRU14071319PS1 & BRU14071319PS2

Mixtard® 30 100IU/ml Insulin Human, rDNA ( as Isophane Insulin) 70%, Insulin Human, rDNA (as soluble insulin) 30%

Novo Nordisk A/S, Bagsvaerd, Denmark (S1); Novo Nordisk Productions SAS, France (S2)

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

903 BRU14071320P Protopic Ointment 0.03% Tacrolimus 0.3mg/g (0.03%) Astellas Pharma Tech Co., Ltd., Japan

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

904 BRU14071321P Beathorphan Elixir 15mg/5ml Dextromethorphan HBr 15mg/5ml Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 02 July 2019 till 01 July 2024

POM

905 BRU14071324P Luvox® Film-coated Tablets 50mg

Fluvoxamine maleate 50mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

906 BRU14071325P Luvox® Film-coated Tablets 100mg

Fluvoxamine maleate 100mg Abbott Healthcare SAS, France Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

907 BRU14071326P TobraDex® Eye Ointment Tobramycin 0.3%, Dexamethasone 0.1%

S.A. Alcon-Couvreur N.V., Belgium

Medipharm Sdn Bhd 02 July 2019 till 01 July 2024

POM

908 BRU14071328P Lanvis® Tablet 40mg Thioguanin 40mg Excella GmbH & Co. KG., Germany

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

909 BRU14071329NP Axcel Papain Tablet Papain Pure equiv. to proteolytic enzymes from carica papaya 10,000 USP Units

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 02 July 2019 till 01 July 2024

GSL

910 BRU14071330P Humalog® KwikPenTM 100units/mL

Insulin Lispro 100units/ml Lilly France S.A.S., France (repacker - Eli Lilly And Company, USA)

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

BDMCA/RMP/1220 Page 62 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

911 BRU14071331P Shincort IM Injection "Yung Shin" 40mg/ml ampoules

Triamcinolone acetonide 40mg Yung Shin Pharmaceutical Ind. Co. Ltd., Taiwan

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

912 BRU14071332P Emend IV Powder For Solution for Infusion 150mg

Fosaprepitant 150mg (as fosaprepitant dimeglumine)

DSM Pharmaceuticals Inc., USA Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

913 BRU14071333PS1; BRU14071333PS2

Zytiga Tablets 250mg Abiraterone acetate 250mg Patheon Inc. Canada (S1); Patheon S.A.S. (Patheon-France), France (S2)

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

914 BRU14071334P Axcel Cefaclor-500 Capsule Cefaclor 500mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 02 July 2019 till 01 July 2024

POM

915 BRU14071335P Anlodin Tablet 5mg Amlodipine 5mg (as Besylate 6.93mg) Y.S.P Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

916 BRU14071336P Aldara Cream 5%w/w Imiquimod 5% w/w 3M Health Care Limited, England Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

917 BRU14071337P Premarin Tablet 0.3mg Conjugated estrogens 0.3mg Pfizer Ireland Pharmaceuticals, Ireland

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

918 BRU14071342P Axcel Ibuprofen Paediatric Syrup

Ibuprofen 100mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 02 July 2019 till 01 July 2024

P

919 BRU14071344P Bislan Tablet 8mg Bromhexine Hydrochloride 8mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024

P

920 BRU14071345P Tren Capsules 250mg Tranexamic Acid 250mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

921 BRU14071346P Hydrocort Cream Hydrocortisone acetate 10mg/g (1% w/w)

Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024

P

922 BRU14071348P Pharmaniaga Atropine Sulphate 1 mg/ml

Atropine Sulphate 1mg/ml Pharmaniaga Lifesciences Sdn Bhd, Malaysia

G & H Trading Company 02 July 2019 till 01 July 2024

POM

923 BRU14071352P Ipolipid 600mg Tablets Gemfibrozil 600mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 02 July 2019 till 01 July 2024

POM

924 BRU14071353P Salbutamol Injection 0.5mg/ml

Salbutamol Sulphate 0.5mg/ml (equivalent to salbutamol base)

Yung Shin Pharmaceutical Ind., Co. Ltd., Taichong, Taiwan

Asterix United (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

925 BRU14071355P Axcel Dexchlorpheniramine Tablet

Dexchlorpheniramine 2mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 02 July 2019 till 01 July 2024

POM

926 BRU14071357P Quinine Sulphate Tablet 300mg

Quinine Sulphate BP 300mg Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 02 July 2019 till 01 July 2024

POM

927 BRU14071358NP 20% Glucose Intravenous Infusion BP

Glucose (as monohydrate) 20% B. Braun Medical Industries Sdn Bhd Malaysia

Hongkiat Trading & Co 02 July 2019 till 01 July 2024

POM

928 BRU14071359P Pharmaniaga Spironolactone Tablet 25mg

Spironolactone 25mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 02 July 2019 till 01 July 2024

POM

929 BRU14071360P Maxidex Sterile Opthalmic Suspension

Dexamethasone 0.1% ( 1mg/ml) S.A. Alcon-Couvreur N.V., Belgium

Medipharm Sdn Bhd 02 July 2019 till 01 July 2024

POM

930 BRU14071361P Heparinol 1000IU/ml Heparin sodium (bovine) BP 1000IU/ml Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 02 July 2019 till 01 July 2024

POM

BDMCA/RMP/1220 Page 63 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

931 BRU14071362P Alphagan Ophthalmic Solution 0.2%

Brimonidine tartrate (anhydrous basis) 2mg/ml

Allergan Pharmaceuticals Ireland, Ireland

Medipharm Sdn Bhd 02 July 2019 till 01 July 2024

POM

932 BRU14071367P Invega Sustenna Prolonged Release Suspension for IM Injection 150mg/1.5ml

Paliperidone 150mg/1.5ml (as palmitate 234mg)

Janssen Pharmaceutical NV, Belgium

Zuellig Pharma (B) Sdn Bhd 02 July 2019 till 01 July 2024

POM

933 BRU14071368P Yondelis® Powder for Injection 1mg/vial

Trabectedin 0.05mg/ml Baxter Oncology GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

934 BRU14071369P Trajenta film-coated tablet 5mg

Linagliptin 5mg West-Ward Columbus Inc. Hongkiat Trading & Company 24 July 2019 till 23 July 2024

POM

935 BRU14071370P Novoseven® 1mg Powder and Solvent for Solution for Injection

Eptacog alfa (activated) 1mg/ml (corresponds to 50KIU/vial) - 1mg/ml after reconstitution

Novo Nordisk A/S, Gentofte, Denmark; Novo Nordisk A/S, Kalundborg, Denmark

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

936 BRU14071372PS1 & BRU14071372PS2

Invega® Extended-Release Tablet 9mg

Paliperidone 9mg [Layer 1 - 2.7mg; Layer 2 - 6.3mg]

ALZA Corporation, USA (S1); Janssen Cilag Manufacturing L.L.C., Puerto Rico (S2)

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

937 BRU14071373PS1 & BRU14071373PS2

Invega® Extended-Release Tablet 3mg

Paliperidone 3mg [Layer 1 - 0.9mg; Layer 2 - 2.1mg]

ALZA Corporation, USA (S1); Janssen Cilag Manufacturing L.L.C., Puerto Rico (S2)

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

938 BRU14071374PS1 & BRU14071374PS2

Invega® Extended-Release Tablet 6mg

Paliperidone 6mg [Layer 1 - 1.8mg; Layer 2 - 4.2mg]

ALZA Corporation, USA (S1); Janssen Cilag Manufacturing L.L.C., Puerto Rico (S2)

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

939 BRU14071375P Lucentis 10mg/ml Solution for Injection

Ranibizumab 10mg/ml Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

940 BRU14071376P Onbrez Breezhaler 150mcg Inhalation Powder, Hard Capsule

Indacterol 150mcg (as maleate 194mcg)

Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

941 BRU14071377P Onebrez Breezhaler 300mcg Inhalation Powder Hard Capsule

Indacterol 300mcg (as maleate 389mcg)

Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

942 BRU14071378P Requip PD 24hr Prolong Release Tablet 2mg

Ropinirole 2mg (as Hydrochloride) Glaxo Wellcome SA Spain Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

943 BRU14071379P Difflam Anti-Inflammatory Lozenges (with Anti-bacterial)

Benzydamine Hydrochloride 3mg; Cetylpyridinium Chloride 1.33mg

Unique Pharmaceutical Laboratories, India

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

GSL

944 BRU14071380P Vfend Powder For Oral Suspension 40mg/ml

Voriconazole 40mg/ml Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

945 BRU14071381P Norditropin® NordiFlex Solution for Injection 10mg/1.5ml

Somatropin (biosynthetic human growth hormone) 10mg/1.5ml

Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

946 BRU14071382P Alphagan P Ophthalmic Solution 0.15%

Brimonidine tartrate 0.15% Allergan Sales LLC, USA Medipharm Sdn Bhd 24 July 2019 till 23 July 2024

POM

BDMCA/RMP/1220 Page 64 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

947 BRU14071383P Mapenem® IV Injection 500mg

Meropenem 500mg (as trihydrate) Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 24 July 2019 till 23 July 2024

POM

948 BRU14071384P Curam Powder for oral Suspension 312.5mg/5ml

Amoxycillin 250mg (as trihydrate); Clavulanic Acid 62.5mg (as potassium salt)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2024 till 23 July 2029

POM

949 BRU14071385P Topamax® 25 Tablet 25mg Topiramate 25mg CILAG AG, Switzerland Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

950 BRU14071386P Tussils 5 Lozenge 5mg Dextromethorphan Hydrobromide 5mg Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

951 BRU14071387P Kivexa Tablets 600mg/300mg Abacavir 600mg (as sulfate); Lamivudine 300mg

GlaxoSmithKline Pharmaceuticals S.A, Poland [Repacker: Glaxo Wellcome, S.A., Spain]

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

952 BRU14071388P Lucrin® depot 3.75mg Injection

Leuproprelin acetate 3.75mg Takeda Pharmaceutical Company Limited, Japan [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

953 BRU14071389P Lucrin® depot 11.25mg Injection

Leuproprelin acetate 11.25mg Takeda Pharmaceutical Company Limited, Japan [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

954 BRU14071390P Axcel Diclofenac-50 Tablet Diclofenac Sodium 50mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 24 July 2019 till 23 July 2024

POM

955 BRU14071392P Infasurf® (Calfactant) Intratracheal Suspension

Per ml - Phospholipids 35mg (including 26mg phosphatidycholine of which 16mg is disaturated phosphatidycholine) and 0.7mg protein (incuding 0.26mg of SP-B0Calfactant [Calf lung Surfactant Extract -CLSE]

ONY Biotech Inc., USA K-Seri Pharma 24 July 2019 till 23 July 2024

POM

956 BRU14071394P Duodart 0.5mg/0.4mg Capsules

Dutasteride 0.5mg; Tamsulosin 0.4mg Catalent Germany Schorndorf GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

957 BRU14071395P Axcel Metronidazole-400 Tablet

Metronidazole 400mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 24 July 2019 till 23 July 2024

POM

958 BRU14071396P Cefazolin Sandoz 1g Vial Cefazolin 1g Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 24 July 2024 till 23 July 2029

POM

BDMCA/RMP/1220 Page 65 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

959 BRU14071397PS1; BRU14071397PS3; BRU14071397PS4

MABTHERA Concentrate for Solution for Infusion 500mg/50ml

Rituximab 500mg/50ml Genetech Inc., South San FranciscoCA, USA (S1); Roche Diagnostics GmbH, Germany (S3); Genentech Inc., Hilsboro, OR, USA (S4)

MediPharm Sdn Bhd 24 July 2019 till 23 July 2024

POM

960 BRU14071398P Lamitor 100mg Tablet Lamotrigine 100mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 24 July 2019 till 23 July 2024

POM

961 BRU14071399PS1 & BRU14071399PS2

Vigamox® Ophthalmic Solution 0.5%

Moxifloxacin 0.5% (as hydrochloride) ALCON LABORATORIES, INC., USA (S1)

Alcon Singapore Manufacturing Pte. Ltd., Singapore (S2)

Medipharm Sdn Bhd 24 July 2019 till 23 July 2024

POM

962 BRU14071401PS1 & BRU14071401PS2

Voltaren Emulgel 1% Diclofenac diethylamine 1.16g/100g (equivalent to 1g of diclofenac sodium)

Novartis Pharma Produktions GmbH, Germany (S1 for pack size 50g) & GSK Consumer Healthcare S.A., Switzerland (S2 for pack size 20g)

Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

GSL

963 BRU14071402P Imexa Film-Coated Tablet 250mg

Azithromycin 250mg (as dihydrate) Xepa-Soul Pattinson (M) Sdn Bhd Malaysia

Hongkiat Trading & Co 24 July 2019 till 23 July 2024

POM

964 BRU14071403P Cymbalta Capsule 60mg Duloxetine (as hydrochloride) 60mg Lilly del Caribe Inc, Puerto Rico Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

965 BRU14071404P Beanamine Expectorant Per 5ml - Diphenhydramine BP 10mg; Ammonium Chloride BP 120mg)

Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 24 July 2019 till 23 July 2024

POM

966 BRU14071405P Setrof Tablet 50mg Sertraline 50mg Hovid Bhd, Malaysia G & H Trading Company 24 July 2019 till 23 July 2024

POM

967 BRU14071408P Melashine Cream 4% Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

968 BRU14071409P Asumalife Syrup 1.38mg/5ml Per 5ml - Ketotifen 1mg (as hydrogen fumarate 1.38mg)

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

969 BRU14071410P Lovastin Tablet 20mg Lovastatin 20mg Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

970 BRU14071411P Requip tablet 0.25mg Ropinirole 0.25mg (as Hydrochloride) Glaxo Wellcome S.A., Spain Zuellig Pharma (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

971 BRU14071412NP Zoben Tablet 200mg Albendazole 200mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 24 July 2019 till 23 July 2024

P

972 BRU14071414P Garbose Tablet 50mg Acarbose 50mg Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 24 July 2019 till 23 July 2024

POM

BDMCA/RMP/1220 Page 66 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

973 BRU14071415P Dexamethasone 4mg Tablet Dexamethasone 4mg Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 24 July 2019 till 23 July 2024

POM

974 BRU14081416PS1; BRU14081416PS2

Sevorane Inhalation Liquid Sevoflurane 100%v/v Aesica Queensborough Ltd, UK (S1); Abbvie S.R.L, Italy (S2) [Secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

975 BRU14081417PS2 Emend Tri-Pack Capsule Each capsule either contains Aprepitant 80mg or 125mg

Alkermes Pharma Ireland Limited, Ireland (S2) Repackers: 2) PT. Merck Sharp Dohme Pharma Tbk., Indonesia. (Primary and secondary packaging and release)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

976 BRU14081418P Protopic Ointment 0.1% Tacrolimus (as Tacrolimus monohydrate) 0.1%

Astellas Pharma Tech Co., Ltd., Japan

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

977 BRU14081419PS2 Exforge HCT 10/160/12.5mg Film-coated tablet

Amlodipine 10mg (as besylate); Valsartan 160mg; Hydrochlorothiazide 12.5mg

Novartis Farmaceutica SA, Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

978 BRU14081420PS2 Exforge HCT 10/160/25mg Film-coated tablet

Amlodipine 10mg (as besylate); Valsartan 160mg; Hydrochlorothiazide 25mg

Novartis Farmaceutica SA, Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

979 BRU14081421PS4 Exforge HCT 5/160/12.5mg Film-coated tablet

Amlodipine 5mg (as besylate); Valsartan 160mg; Hydrochlorothiazide 12.5mg

Novartis Farmaceutica SA, Barcelona, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

980 BRU14081424P Luveris for Injection 75IU/Vial (Revised Formula)

Lutropin alfa 75IU (Recombinant Human Lutenising Hormone)

Merck Serono SA., Switzerland G & H Trading Company 30 August 2019 till 29 August 2024

POM

981 BRU14081425P Lipanthyl Penta 145 Film-Coated tablet

Fenofibrate 145mg Recipharm Fontaine, France Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

982 BRU14081426P Dexamethasone Tablet 0.5mg Dexamethasone 0.5mg Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 30 August 2019 till 29 August 2024

POM

983 BRU14081428PS1 BRU14081428PS2

JanumetTM Tablet 50mg/850mg

Sitagliptin 50mg (as phosphate); Metformin HCl 850mg

Patheon Puerto Rico, Inc., Manati, PR 00674, Puerto Rico (S1) & Aesica Queensborough Limited, UK (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

984 BRU14081429PS1 BRU14081429PS2

JanumetTM Tablet 50mg/500mg

Sitagliptin 50mg (as phosphate); Metformin HCl 500mg

Patheon Puerto Rico, Inc., Manati, PR 00674, Puerto Rico (S1) & Aesica Queensborough Limited, UK (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

BDMCA/RMP/1220 Page 67 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

985 BRU14081430PS1 BRU14081430PS2

JanumetTM Tablet 50mg/1000mg

Sitagliptin 50mg (as phosphate); Metformin HCl 1000mg

Patheon Puerto Rico Inc., Manati, Puerto Rico (S1) & Aesica Queensborough Limited, UK (S2)

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

986 BRU14081432PS1; BRU14081432PS3; BRU14081432PS4

Mabthera Concentrate for Solution for Infusion 100mg/10ml

Rituximab 100mg/10ml Genetech Inc., South San FranciscoCA, USA (S1); Roche Diagnostics GmbH, Germany (S3); Genentech Inc., Hilsboro, OR, USA (S4)

MediPharm Sdn Bhd 30 August 2019 till 29 August 2024

POM

987 BRU14081433P EraxisTM 100mg for Injection Anidulafungin 100mg/vial Pharmacia & Upjohn Company LLC, USA

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

988 BRU14081434P Moxiclav 1G Tablet Amoxycillin 875mg (as sodium); Clavulanic Acid 125mg (as Clavulanate potassium)

Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 August 2019 till 29 August 2024

POM

989 BRU14081435P Lisdene 10mg tablet Lisinopril 10mg (as dihydrate) Lek Pharmaceuticals D.D., Slovenia

Zuellig Pharma (B) Sdn Bhd 30 August 2024 till 29 August 2029

POM

990 BRU14081439P Carzepin 200mg Tablet Carbamazepine 200mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2019 till 29 August 2024

POM

991 BRU14081440P Naphcon-A Sterile Ophthalmic Solution

Naphazoline Hydrochloride 0025%; Pheniramine maleate 0.3%

S.A. Alcon-Couvreur N.V., Belgium

Hongkiat Trading & Co 30 August 2019 till 29 August 2024

P

992 BRU14081441P Lamictal 100mg Tablet Lamotrigine 100mg Glaxosmithkline Pharmaceuticals SA, Poland

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

993 BRU14081442P Axcel Loratadine Tablet Loratadine 10mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 August 2019 till 29 August 2024

P

994 BRU14081447P Axcel Cefaclor-125 Suspension Cefaclor 125mg (as monohydrate) Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 August 2019 till 29 August 2024

POM

995 BRU14081448P Dextramine Tablet 2mg Dexchlorpheniramine 2mg Chulia Pharma Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 30 August 2019 till 29 August 2024

POM

996 BRU14081449P; BRU14081449PS2

Mircera Pre-filled Syringe 75mcg/0.3ml

Methoxy polyethylene glycol-epoetin Beta 75mcg/0.3ml

Roche Diagnostics GmbH, Germany; F. Hoffmann-La Roche AG, Kaiseraugst, Switzerland (S2)

MediPharm Sdn Bhd 30 August 2019 till 29 August 2024

POM

997 BRU14081450P Creobic Cream Clotrimazole 1%w/w Kotra Pharma (M) Sdn Bhd, Malaysia

Yuh Hua Trading Company 30 August 2019 till 29 August 2024

GSL

998 BRU14081451P Axcel Cetirizine Syrup Cetirizine Dihydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 August 2019 till 29 August 2024

P

999 BRU14081453P Sunex Cough Syrup Per 5ml - Diphenhydramine HCl 14mg; Ammonium chloride 135mg; Sodium/ Trisodium citrate 57.5mg

Sunward Pharmaceutical Sdn Bhd Malaysia

G & H Trading Company 30 August 2019 till 29 August 2024

POM

1000 BRU14081455P Proluton Depot 250mg Injection

Hydroxyprogesterone Caproate 250mg Bayer AG, Berlin, Germany Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

BDMCA/RMP/1220 Page 68 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1001 BRU14081456P Nurofen for Children Ibuprofen 100mg/5ml Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

P

1002 BRU14081457P Axcel Sabutamol Syrup Salbutamol 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 30 August 2019 till 29 August 2024

POM

1003 BRU14081458P Doxymycin Capsule 100mg Doxycycline Hydrochloride 100mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

1004 BRU14081459P Clamentin Powder for Syrup 31.25mg/ml

Per ml - Amoxycillin 25mg (as trihydrate); Clavulanic acid 6.25mg (as potassium salt)

Yung Shin Pharmaceutical Ind. Co., Ltd, Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

1005 BRU14081460P Clarimycin Film Coated Tablet 500mg

Clarithromycin 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

1006 BRU14081461NP Mentar Shampoo Coal Tar solution 9% v/v; Menthol 1% w/w

HOE Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 30 August 2019 till 29 August 2024

GSL

1007 BRU14081462NP Menzza Cream Methyl Salicylate 25%w/w; Menthol 5%w/w

Hoe Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 30 August 2019 till 29 August 2024

GSL

1008 BRU14081465NP Bayer Aspirin Tablet 500mg Aspirin 500mg (Acetylsalicylic acid) PT Bayer Indonesia, Indonesia Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

GSL

1009 BRU14081467P; BRU14081467PS2

Tobradex® Eye Drops Suspension

Tobramycin 0.3%; Dexamethasone 0.1%

S.A. Alcon-Couvreur N.V., Belgium; Alcon Singapore Manufacturing Pte. Ltd., Singapore (S2)

Medipharm Sdn Bhd 30 August 2019 till 29 August 2024

POM

1010 BRU14081470P Rotaqor 10mg film-coated tablet

Atorvastatin 10mg (as calcium) Lek Pharmaceuticals D.D., Slovenia

Zuellig Pharma (B) Sdn Bhd 30 August 2024 till 29 August 2029

POM

1011 BRU14081473P Clofenac SR Tablet Diclofenac Sodium 100mg Hovid Bhd, Malaysia G & H Trading Company 30 August 2019 till 29 August 2024

POM

1012 BRU14081474P Strepsils Max Plus Lozenges 2,4 Dichlorobenzyl alcohol 1.2mg; amymetacresol 0.6mg; Lignocaine Hydrochloride 10mg

Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

GSL

1013 BRU14081475P Cera-Scalp Ointment Coal Tar solution 12% w/w; Salicylic acid 2%; Sulphur 4% w/w

HOE Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 30 August 2019 till 29 August 2024

GSL

1014 BRU14081476P Lisdene 20mg Tablet Lisinopril 20mg (as dihydrate) Lek Pharmaceuticals DD., Slovenia

Zuellig Pharma (B) Sdn Bhd 30 August 2024 till 29 August 2029

POM

1015 BRU14091477P Suprane Inhalation Liquid 100%

Desflurane 100% Baxter Healthcare Corporation, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 August 2019 till 29 August 2024

POM

1016 BRU14091478P Buclizine Tablet 25mg Buclizine 25mg Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 30 August 2019 till 29 August 2024

P

1017 BRU14091479PS1; BRU14091479PS2

Cetrotide Injection 0.25mg Cetrotrelix 0.25mg (as Acetate) Baxter Oncology GmbH, Germany (S1); Pierre Fabre Medicament Production, France (S2)

G & H Trading Company 30 September 2019 till 29 September 2024

POM

BDMCA/RMP/1220 Page 69 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1018 BRU14091480P Mivacron Injection 10mg/5ml Mivacurium Chloride 10mg/5ml GlaxoSmithKline Manufacturing S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1019 BRU14091481P Xolair Powder and Solvent for Solution for Injection

Omalizumab 150mg Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1020 BRU14091483P Pengesic 50 Capsule Tramadol HCl 50mg Hovid Bhd, Malaysia G & H Trading Company 30 September 2019 till 29 September 2024

POM

1021 BRU14091486P Crinone Progestrone Vaginal Gel 8%

Progestrone 8% Dendron Brands Limited, United Kingdom

G & H Trading Company 30 September 2019 till 29 September 2024

POM

1022 BRU14091487NP Pinetarsol Gel Tar 1.6% EGO Pharmaceuticals Pty Ltd., Australia

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

GSL

1023 BRU14091488P Defungo (Vaginal Tablet 0.1g) Clotrimazole 0.1g Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 30 September 2019 till 29 September 2024

P

1024 BRU14091489P Magrilan 20mg capsules Fluoxetine 20mg (as Hydrochloride) Medochemie Ltd., Cyprus Hongkiat Trading & Co 30 September 2019 till 29 September 2024

POM

1025 BRU14091490P Trileptal 600mg Film-coated Tablets

Oxcarbazepine 600mg Novartis Farma S.p.A., Italy Medipharm Sdn Bhd 30 September 2019 till 29 September 2024

POM

1026 BRU14091491P Binozyt 500mg film-coated tablet

Azithromycin 500mg (as monohydrate) Novartis (Bangladesh) Ltd., Bangladesh

Zuellig Pharma (B) Sdn Bhd 30 September 2024till 29 September 2029

POM

1027 BRU14091494P Eprex® 10000 Prefilled Syringes 10,000iu/1ml

Epoetin alfa 10,000 IU/ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1028 BRU14091501P Yucomy cream Ketoconazole 20g/g Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29 September 2024

GSL

1029 BRU14091502P Loradine Tablet 10mg Loratadine 10mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29 September 2024

p

1030 BRU14091503P Rasitol Tablet 40mg Furosemide 40mg YSP Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1031 BRU14091504P Betoptic S Eye Drops Betaxolol 2.5mg/ml (as Hydrochloride 2.8mg)

S.A. Alcon-Couvreur N.V., Belgium

Medipharm Sdn Bhd 30 September 2019 till 29 September 2024

POM

1032 BRU14091508P Glucagen® 1mg Powder and Solvent for Solution for Injection

Glucagon 1mg (as hydrochloride) Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1033 BRU14091509P Chloramine Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 30 September 2019 till 29 September 2024

p

1034 BRU14091511NP 0.9% Sodium Chloride Injection, B.P. (10ml)

Sodium Chloride 0.9% B. Braun Medical Industries Sdn Bhd Malaysia

Hongkiat Trading & Co 30 September 2019 till 29 September 2024

GSL

1035 BRU14091512NP Compound Sodium Lactate Intravenous Infusion B.P. (Hartmann's Solution)

Per 1000ml contains: Sodium Chloride 6g; Sodium Lactate solution 6.24g (50% w/w); Potassium Chloride 0.40g; Calcium Chloride dehydrate 0.27g

B. Braun Medical Industries Sdn Bhd Malaysia

Hongkiat Trading & Co 30 September 2019 till 29 September 2024

POM

BDMCA/RMP/1220 Page 70 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1036 BRU14091513P HBVaxPro® 5mcg/0.5ml Injection

Hepatitis B surface Antigen 5mcg/0.5ml Merck Sharp & Dohme Corp., West Point, Pensylvania, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1037 BRU14091514P HBVaxPro® 10mcg/1.0ml Injection

Hepatitis B surface Antigen 10mcg/1.0ml

Merck Sharp & Dohme Corp., West Point, Pensylvania, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1038 BRU14091515P HBvaxPro® 40mcg/1.0ml Injection

Hepatitis B surface Antigen 40mcg/1.0ml

Merck Sharp & Dohme Corp., USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1039 BRU14091519P Afinitor 5mg Tablet Everolimus 5mg Novartis Pharma Stein AG, Switzerland

MediPharm Sdn Bhd 30 September 2019 till 29 September 2024

POM

1040 BRU14091520NP Renacid K8 Each 1 Litre contains: Sodium Chloride 161.43g, Potassium Chloride 5.49g, Calcium Chloride 2H2O 6.77g, Magnesium Chloride 6H2O 3.74g, Glacial acetic acid 8.85g

Ain Medicare Sdn Bhd Malaysia Syarikat Pakatan Indah 30 September 2019 till 29 September 2024

GSL

1041 BRU14091523NP Poviderm Ointment Povidone Iodine 10% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 30 September 2019 till 29 September 2024

GSL

1042 BRU14091524P Melaquin Cream 4% w/w Hydroquinone 40mg/g Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29 September 2024

P

1043 BRU14091526P Glucomet Tablet 500mg Metformin Hydrochloride 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1044 BRU14091527P Quemox Tablet 500mg Mebendazole 500mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 30 September 2019 till 29 September 2024

P

1045 BRU14091528P Campto 300mg/15ml Injection Irinotecan Hydrochloride Trihydrate 300mg/15ml

Pfizer (Perth) Pty Ltd, Australia Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1046 BRU14091529NP Strepsils Cool Lozenges Each lozenge contains: Amymetacresol 0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg

Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Syarikat Aliaa Sdn Bhd 30 September 2019 till 29 September 2024

GSL

1047 BRU14091530NP Strepsils Sugar Free Lemon Lozenges

Each lozenge contains: Amymetacresol 0.6mg, 2,4-Dichlorobezyl alcohol 1.2mg

Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Syarikat Aliaa Sdn Bhd 30 September 2019 till 29 September 2024

GSL

1048 BRU14091533P Ansures Extended Release Tablet 500mg

Metformin Hydrochloride 500mg Siu Guan Chem, Ind. Co. Ltd., Taiwan

G & H Trading Company 30 September 2019 till 29 September 2024

POM

1049 BRU14091534P Deplatt Tablet 75mg Clopidogrel 75mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 30 September 2019 till 29 September 2024

POM

BDMCA/RMP/1220 Page 71 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1050 BRU14091535NP Livolin Forte Softgel Capsules Per Capsule: Lecithin [PC 35%] 857.13mg (equivalent to Phosphatidylcholine 300mg), Di-alpha-tocopheryl acetate 10mg, Thiamine mononitrate 10mg, Riboflavin 6mg, Pyridoxine hydrochloride 10mg, Vitamin B12 0.1% WS 15mg (equivalent to Vitamin B12 0.015mg), Nicotinamide 30mg.

Mega Lifesciences Public Company Limited, Thailand

Hongkiat Trading & Co 30 September 2019 till 29 September 2024

GSL

1051 BRU14091538P Clamentin Injection 1.2g Amoxicillin 1g (as sodium), Clavulanic acid 0.2g (as clavulanate potassium)

Yung Shin Phamaceutical Ind. Co Ltd, Taiwan, ROC

Asterix United (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1052 BRU14091540P Eturion 10mg Film Coated Tablet

Atorvastatin 10mg (as crystalline atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto Rico

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1053 BRU14091541P Eturion 20mg Film Coated Tablet

Atorvastatin 20mg (as crystalline atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1054 BRU14091542P Eturion 40mg Film Coated Tablet

Atorvastatin 40mg (as crystalline atorvastatin calcium)

Pfizer Pharmaceutical LLC, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1055 BRU14091543P Eturion 80mg Film Coated Tablet

Atorvastatin 80mg (as crystalline atorvastatin calcium)

Pfizer Pharmaceuticals LLC, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 30 September 2019 till 29 September 2024

POM

1056 BRU14111544P (vial) EYLEA Solution for Injection (vial)

Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New York, USA; Vetter Pharma-Fertigung GmbH & Co. KG (Langenargen Manufacturing Plant), Langenargen, Germany and Bayer AG, Berlin, Germany (Manufacture of filled vial (including sterile filtration, filling – primary packaging), In-process testing, Quality control testing of filled vial, Visual inspection and interim storage of filled vial)

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1057 BRU14111545P EYLEA Solution for Injection (pre-filled syringe)

Aflibercept 40mg/ml Regeneron Pharmaceuticals Inc., New York, USA

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1058 BRU14111546P Binocrit Solution for Injection 2000 IU/ml in Pre-filled Syringe

Epoetin Alfa 2,000 IU/ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2024 till 31 October 2029

POM

BDMCA/RMP/1220 Page 72 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1059 BRU14111547P Binocrit Solution for Injection 4000 IU/0.4ml in Pre-filled Syringe

Epoetin Alfa 4,000IU/0.4ml IDT Biologika GmbH, Germany Zuellig Pharma (B) Sdn Bhd 01 November 2024 till 31 October 2029

POM

1060 BRU14111550P Advagraf Prolonged Release Hard Capsule 0.5mg

Tacrolimus 0.5mg (as monohydrate) Astellas Ireland Co Ltd., Ireland MediPharm Sdn Bhd 01 November 2019 till 31 October 2024

POM

1061 BRU14111551P Advagraf Prolonged Release Hard Capsule 1mg

Tacrolimus 1mg (as monohydrate) Astellas Ireland Co Ltd., Ireland MediPharm Sdn Bhd 01 November 2019 till 31 October 2024

POM

1062 BRU14111552P Advagraf Prolonged Release Hard Capsule 5mg

Tacrolimus 5mg (as monohydrate) Astellas Ireland Co Ltd., Ireland MediPharm Sdn Bhd 01 November 2019 till 31 October 2024

POM

1063 BRU14111553P Dynastat Injection 40mg Parecoxib (as Sodium) 40mg Pharmacia & Upjohn Company LLC, USA

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1064 BRU14111554P Invanz Powder for Injection 1g/vial

Ertapenem 1g (as Sodium 1.046g) Laboratories Merck Sharp & Dohme-Chibret, France

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1065 BRU14111555P Humalog Mix25 100 units/ml Kwikpen

Insulin Lispro 100IU/ml [In the proportion of 25% Insulin Lispro & 75% Insulin Lispro Protamine Suspension (rDNA origin)

Lilly France S.A.S., France (S1) (repacker - Eli Lilly And Company, USA)

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1066 BRU14111556P Brozil Capsule 300mg Gemfibrozil 300mg YSP Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1067 BRU14111557NP Menzza Ice Gel Menthol 4% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 01 November 2019 till 31 October 2024

GSL

1068 BRU14111558P Trileptal Film-coated Tablets 300mg

Oxcarbazepine 300mg Novartis Farma S.p.A., Italy Medipharm Sdn Bhd 01 November 2019 till 31 October 2024

POM

1069 BRU14111559NP Alka Seltzer Lemon Acetylsalicylic Acid 324mg; Sodium Bicarbonate 1.737g; Citric Acid (anhydrous) 1.223g.

Bayer de Mexico SA De CV, Mexico

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

GSL

1070 BRU14111560P Voren Plus Gel Diclofenac sodium 10mg/g (1%w/w) Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 01 November 2019 till 31 October 2024

GSL

1071 BRU14111561NP Strepsils Original Lozenges Amylmetacresol 0.6mg; 2,4-Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Syarikat Aliaa Sdn Bhd 01 November 2019 till 31 October 2024

GSL

1072 BRU14111562NP Strepsils Orange with Vitamin C Lozenges

Amylmetacresol 0.6mg; 2,4-Dichlorobenzyl Alcohol 1.2mg; Ascorbic Acid 33.5mg; Sodium Ascorbate 74.9mg

Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Syarikat Aliaa Sdn Bhd 01 November 2019 till 31 October 2024

GSL

1073 BRU14111564P Axcel Promethazine-5 Syrup Promethazine Hydrochloride 5mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 01 November 2019 till 31 October 2024

POM

1074 BRU14111565P NIMBEXTM Injection 2mg/ml (5ml)

Cisatracurium Besylate 10mg/5ml GLaxoSmithKline Manufacturing S.p.A., Italy

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

BDMCA/RMP/1220 Page 73 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1075 BRU14111566P Aggrastat Concentrate for Infusion 0.25mg/ml

Tirofibon 0.25mg/ml (as hydrochloride monohydrate 0.281mg/ml)

Patheon Manufacturing Services LLC, USA & Orion Corporation, Espoo, Finland (repacker)

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1076 BRU14111567P Promezine Syrup 1mg/ml Promethazine Hydrochloride 1mg/ml Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1077 BRU14111568P Cephanmycin Capsules 500mg Cephalexin 500mg Yung Shin Pharmaceutical Ind. Co. Ltd., Taiwan

Asterix United (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1078 BRU14111569P; BRU14111569PS2

Ferinject® 50mg Iron/ml solution for Injection/Infusion

Iron 50mg/ml (as ferric carboxymaltose)

BIPSO GmbH, Germany; IDT Biologika GmbH, Germany (S2) [secondary packaging site: Takeda GmbH, Germany; Zuellig Pharma Specialty Solutions Group,Singapore; Vifor (International) Inc., Switzerland)

K-Seri Pharma Sdn Bhd 01 November 2019 till 31 October 2024

POM

1079 BRU14111570P Olmetec Plus 20/12.5mg Film-coated Tablet

Olmesartan Medoxomil 20mg; Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH, Germany; Pfizer Manufacturing Deutschland GmbH, Germany (primary and secondary packaging site)

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1080 BRU14111572P Rotateq® Rotavirus Vaccine, Live, Oral, Pentavalent

Human-bovine Rotavirus G1 ≥ 2.2 x 106IU; Human-bovine Rotavirus G2 ≥ 2.8 x 106IU; Human-bovine Rotavirus G3 ≥ 2.2 x 106IU; Human-bovine Rotavirus G4 ≥ 2.0 x 106IU; Human-bovine Rotavirus P1 ≥ 2.3 x 106IU

Merck Sharp & Dohme Corp., USA

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1081 BRU14111573P Eliquis Film-coated Tablets 2.5mg

Apixaban 2.5mg Bristol-Myers Squibb Manufacturing Company, Puerto Rico, USA; Catalent Anagni S.r.I, Anagni (FR), Italy (packager)

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1082 BRU14111574P Tren Injection 100mg/ml Tranexamic Acid 100mg/ml Yung Shin Pharmaceutical Ind. Co. Ltd., Taiwan

Asterix United (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1083 BRU14111575P Ryzodeg Flex Touch 100 units/ml

Per 1 ml: Insulin Degludec 70%; Insulin Aspart 30%

Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1084 BRU14111577NP Dettol Antiseptic Germicide Liquid

Parachlorometaxylenol 4.8%w/v Pt. Reckitt Benckiser Indonesia Syarikat Aliaa Sdn Bhd 01 November 2019 till 31 October 2024

GSL

1085 BRU14111578P Tolanz Tablet 5mg Olanzapine 5mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 01 November 2019 till 31 October 2024

POM

BDMCA/RMP/1220 Page 74 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1086 BRU14111579P Tolanz Tablet 10mg Olanzapine 10mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 01 November 2019 till 31 October 2024

POM

1087 BRU14111580P Somin Tablet 2mg Dexchlorpheniramine Maleate 2mg Y.S.P Industries (M) Sdn. Bhd., Malaysia

Asterix United (B) Sdn Bhd 01 November 2019 till 31 October 2024

POM

1088 BRU14111581P Vaminolact Solution Per 100ml: L-Alanine 6.3 g; L-Arginine 4.1g; L-Aspartic Acid 4.1g; L-Cysteine / L-Cystine 1g; L-Glutamic Acid 7.1g; Glycine (Amino Acetic Acid) 2.1g; L-Histidine 2.1g; L-Isoleucine3.1g; L-Leucine 7g; L-Lysine 5.6g; L-Methionine 1.3g; L-Phenylalanine 2.7g; L-Proline 5.6g; L-Serine 3.8g; Taurine 300mg; L-Threonine 3.6g; L-Tryptophan 1.4g; L-Tyrosine 500mg; L-Valine 3.6g

Fresenius Kabi Austria GmbH, Austria

Zuellig Pharma (B) Sdn Bhd 01 November 2019 till 31 October 2024

P

1089 BRU14111582P Covinace Tablet 4mg Perindopril Ter-butylamine 4mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 01 November 2019 till 31 October 2024

POM

1090 BRU14111583NP Oralite Natural Oral Rehydration Salts

Per 4.92g sachet: Glucose anhydrous 3.24g; Sodium Chloride 0.624g; Trisodium citrate dihydrate 0.696g; Potassium Chloride 0.36g

Royce Pharma Manufacturing Sdn. Bhd., Malaysia

SWL Biomed Sales & Services 01 November 2019 till 31 October 2024

GSL

1091 BRU14111584NP Panamol Forte Suspension 250mg/5ml

Paracetamol 250mg/5ml Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 01 November 2019 till 31 October 2024

P

1092 BRU14111585PS3, BRU14111585PS4; BRU14111585PS5

Avastin 100mg/4ml Bevacizumab 25mg/ml (Humanised anti-VEGF monoclonal antibody)

Roche Diagnostics GmbH, Manheim, Germany (S3); F Hoffmann-La Roche Ltd, Kaiseraugst, Switzerland (S4); Genentech Inc., Hillsboro, OR, USA (S5)

Hongkiat Trading & Co 01 November 2019 till 31 October 2024

POM

1093 BRU14111586P Zyvox 20mg/ml Granules For Oral Suspension

Linezolid 100mg/5ml Pfizer Pharmaceuticals LLC, USA Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1094 BRU14111587P Axcel Cimetidine-400 Tablet Cimetidine 400mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

POM

1095 BRU14111589P Resolor film-coated tablet 1mg

Prucalopride 1mg (as succinate 1.321mg)

Janssen-Cilag SpA., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1096 BRU14111590NP Maltofer Fol Chewable Tablet Iron (III) 100mg (as hydroxide-polymaltose Complex); Folic acid 0.35mg

Vifor S.A., Switzerland & Iberfar-Industria Farmacetutica S.A., Barcelona, Portugal

Medipharm Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1097 BRU14111591P Pristiq 50mg Extended-Release Tablets

Desvenlafaxine 50mg (as succinate 75.87mg)

Pfizer Ireland Pharmaceuticals, Ireland

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 75 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1098 BRU14111592P ElIquis 5mg Film-coated Tablet Apixaban 5mg Bristol-Myers Squibb Manufacturing Company, Puerto Rico, USA; Catalent Anagni S.r.I, Anagni (FR), Italy (packager)

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1099 BRU14111593P Pulin Film-coated Tablet 10mg Metoclopramide HCl 10mg ( as Mono HCl 10.5mg)

Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1100 BRU14111595P Advate 250 IU Powder and Solvent for Solution for Injection

Octocog alfa (recombinant human coagulation factor VIII) 250 IU

1) Baxalta Manufacturing Sarl, Switzerland (DP manufacturer); 2) Siegfried Hameln GmbH, Germany (Sterile Water for Injection (Diluent) manufacturer)

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1101 BRU14111597NP 0.45% Sodium Chloride and 5% Dextrose Intravenous Infusion B.P

Per 1L - Sodium Chloride 4.5g; Glucose anhdyrous 50g (as monohydrate 55g)

B.Braun Medical Industries Sdn Bhd., Malaysia

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

GSL

1102 BRU14111598PS1 & BRU14111598PS2

Gonal-F 1050IU/1.75ml (77mcg/1.75ml) Powder and Solution for Injection

Per Pen (1.75ml) - Follitropin Alfa 1050IU (equivalent 77mcg) [Per ml of solution contains 600IU Follitropin alfa ~ 44mcg]

Merck Serono S.p.A., Italy (S1) & Merck Serono S.A., Switzerland (S2)

G & H Trading Company 19 May 2020 till 18 May 2025

POM

1103 BRU14111599P Cardiol Tablet 6.25mg Carvedilol 6.25mg Yung Shin Pharmaceutical Ind. Co. Ltd., Taiwan

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1104 BRU14111603P Domper Tablet 10mg Domperidone 10mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1105 BRU14111604NP Davmorid film-coated Tablet Diosmin 450mg; Hesperidin 50mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1106 BRU14111605P Zimmex Tablet 10mg Simvastatin 10mg Silom Medical Co. Ltd., Thailand Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

POM

1107 BRU14111606NP Strepsils Warm Lozenges Amymetacresol 0.6mg; 2,4-Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Syarikat Aliaa Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1108 BRU14111607NP Pharmaniaga Sodium Bicarbonate 8.4% w/v Injection

Sodium Bicarbonate 8.4%w/v (84mg/ml)

Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

POM

1109 BRU14111608P Binozyt 200mg/5ml Powder for Oral Suspension

Azithromycin 200mg Sandoz S.R.L., Romania Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1110 BRU14111611P Kogrel 75mg Film Coated Tablet

Clopidogrel 75mg (as bisulfate 97.875mg)

Sandoz Private Limited, Mumbai, India

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1111 BRU14111612P Chloramine Tablet 4mg Chlorpheniramine maleate 4mg Beacons Pharmaceuticals, Pte ltd, Singapore

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

P

1112 BRU14111613NP Tolnaderm Cream 1% Tolnaftate 1% w/w HOE Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

GSL

BDMCA/RMP/1220 Page 76 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1113 BRU14111614P Medoflucon Capsule 50mg Fluconazole 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1114 BRU14111615P Curam 156.25mg/5ml Powder for Oral Suspension

Per 5ml - Amoxycillin 125mg (as trihydrate); Clavulanic acid 31.25mg

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1115 BRU14111618NP Strepsils Extra Strong Lozenge Amymetacresol 0.6mg; 2,4-Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Syarikat Aliaa Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1116 BRU14111621P Brozil Film coated Tablet 600mg

Gemfibrozil 600mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1117 BRU14111622NP Panadol Extra Tablets Paracetamol 500mg; Caffeine 65mg Sterling Drug (Malaya) Sdn Bhd, Malaysia

Kingston Beverage & Creamery Sdn Bhd

19 May 2020 till 18 May 2025

GSL

1118 BRU14111623P Botox (Botulinium Toxin, Type A) Injection 100units/vial

Clostridium Botulinum Toxin Type A Purified Neurotoxin Complex 100Units/vial

Allergan Pharmaceuticals Ireland, Ireland

Medipharm Sdn Bhd 19 May 2020 till 18 May 2025

POM

1119 BRU14111624P Botox (Botulinium Toxin, Type A) Injection 50units/vial

Clostridium Botulinum Toxin Type A Purified Neurotoxin Complex 50Units/vial

Allergan Pharmaceuticals Ireland, Ireland

Medipharm Sdn Bhd 19 May 2020 till 18 May 2025

POM

1120 BRU14111625P Botox (Botulinium Toxin, Type A) Injection 200units/vial

Clostridium Botulinum Toxin Type A Purified Neurotoxin Complex 200Units/vial

Allergan Pharmaceuticals Ireland, Ireland

Medipharm Sdn Bhd 19 May 2020 till 18 May 2025

POM

1121 BRU14111627P; BRU14111627PS2

Cellcept Tablet 500mg Mycophenolate mofetil 500mg Delpharm Milano S.r.I., Italy; Recipharm Leganes, S.L.U., Spain (S2)

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1122 BRU14111628NP 0.45% Sodium Chloride Intravenous Infusion B.P

Sodium Chloride 0.45% B.Braun Medical Industries Sdn Bhd., Malaysia

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

P

1123 BRU14111629P Xorimax 500mg Coated Tablet Cefuroxime 500mg (as axetil) Sandoz GmbH, Austria; Aurobindo Pharma Limited, India

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1124 BRU14111630P Xorimax 250mg Coated Tablet Cefuroxime 250mg (as axetil) PenCef Pharma GmbH, Germany Sandoz GmbH, Austria; Aurobindo Pharma Limited, India

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1125 BRU14111631NP Peditrace Concentrate for Solution for Infusion

Per 1ml - Zinc Chloride 521mcg; Copper Chloride 2H2O 53.7mcg; Manganese

Chloride 4H2O 3.60mcg; Sodium Selenite anhydrous 4.38mcg; Sodium Fluoride 126mcg; Potassium Iodide 1.31mcg

Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 77 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1126 BRU14111633P Pharmaniaga Salbutamol Respirator Solution 0.5%w/v

Salbutamol 0.5%w/v (as sulphate) Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

POM

1127 BRU14111634P Epimate 50mg Tablet Topiramate 50mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1128 BRU14111635NP HOE Aqueous Cream 9% w/w Emulsifying wax 9.0%w/w; White Soft Paraffin 15% w/w; Liquid Paraffin 6.0% w/w

Hoe Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

GSL

1129 BRU14111636P Melomet Cream 0.1% w/w Mometasone Furoate 0.1% w/w Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1130 BRU14111637NP Poro Suspension 250mg/5ml Paracetamol 250mg/5ml Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1131 BRU14111638P Primovist 0.25mmol/ml solution for injection

Gadoxetic acid, Sodium 0.25mmol/ml Bayer AG, Berlin, Germany Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1132 BRU14111641NP Hoemal Oral Suspension Paracetamol 250mg/5ml (5%) Hoe Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

GSL

1133 BRU14111642P Manace Injection 5mg/ml (Haloperidol 5mg/ml)

Haloperidol 5mg/ml Duopharma (M) Sdn Bhd Malaysia

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1134 BRU14111643NP Woodward's Gripe Water (Alcohol Free)

Per 5ml - Terpeneless Dill Seed Oil 2.3mg; Sodium Bicarbonate 52.5mg

Olic Thailand Limited, Thailand Syarikat Aliaa Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1135 BRU14111644P Buston Injection 20mg/ml Hyoscine-N-butylbromide 20mg/ml Siu Guan Chem, Ind. Co. Ltd., Taiwan

G & H Trading Company 19 May 2020 till 18 May 2025

POM

1136 BRU14111645NP Tolnaderm lotion 1.0%w/v Tolnaftate 1% w/w Hoe Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

GSL

1137 BRU14111646NP Oralite Orange Oral Rehydration Salts

Per 4.95g - Glucose anhydrous 3.24g; Sodium Chloride 0.624g; Trisodium citrate dihydrate 0.696g; Potassium Chloride 0.36g

Royce Pharma Manufacturing Sdn. Bhd., Malaysia

SWL Biomed Sales & Services 19 May 2020 till 18 May 2025

GSL

1138 BRU14111647P Vesyca Film Coated Tablet 150mg

Ranitidine 150mg (as hydrochloride) Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1139 BRU14111648P Pharmaniaga Cetirizine 10mg tablet

Cetirizine 10mg (as hydrochloride) Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

P

1140 BRU14111649P Hovid Lipiduce-20 Tablet Atorvastatin 20mg (as calcium) Hovid Bhd, Malaysia G & H Trading Company 19 May 2020 till 18 May 2025

POM

1141 BRU14111650P Invokana Film-coated Tablet 100mg

Canagliflozin 100mg (as hemihydrate) Janssen-Cilag SpA, Italy Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1142 BRU14111651P Axcel Chlorpheniramine-2 Syrup

Chlorpheniramine maleate 2mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

P

1143 BRU14111652P Binozyt Film-Coated Tablet 250mg

Azithromycin 250mg (as monohydrate) Novartis (Bangladesh) Ltd., Bangladesh

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1144 BRU14111653P Asmol 2 tablet Salbutamol 2mg (as sulphate) Sunward Pharmaceutical Pte. Ltd., Singapore

G & H Trading Company 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 78 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1145 BRU14111654NP Paracetamol Kabi Solution for infusion 10mg/ml

Paracetamol 10mg/ml i) Fresenius Kabi Deutschland GmbH, Germany ii) Fresenius Kabi Austria GmbH, Austria

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1146 BRU14111655P Risperdal Solution 1mg/ml Risperidone 1mg/ml Janssen Pharmaceutical NV, Belgium [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1147 BRU14121661P Kastipron Tablet 375mg S-Carboxymethylcysteine 375mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

P

1148 BRU14121662P Ipolipid Capsules 300mg Gemfibrozil 300mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1149 BRU14121663P Curam 625mg Film-coated Tablet

Amoxicillin 500mg; Clavulanic acid as potassium salt 125mg

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1150 BRU14121664P Vesyca Injection 25mg/ml Ranitidine (as hydrochloride) 25mg/ml Yung Shin Pharmaceutical Ind. Co., Ltd, Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1151 BRU14121666P Amoxicap 500 Capsule Amoxicillin (as trihydrate 574mg) 500mg

Hovid Bhd, Malaysia G & H Trading Company 19 May 2020 till 18 May 2025

POM

1152 BRU14121667NP Wintosal Cream Methyl salicylate 15.0% w/w; Menthol 2.3% w/w and Camphor 4.0% w/w

Hovid Bhd, Malaysia G & H Trading Company 19 May 2020 till 18 May 2025

GSL

1153 BRU14121668NP 50% Glucose Intravenous Infusion B.P.

Glucose monohydrate (550.00g) eq. to anhydrous glucose 500.0g/1000ml

B.Braun Medical Industries Sdn Bhd., Malaysia

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1154 BRU14121670P Medoflucon Capsule 150mg Fluconazole 150mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1155 BRU14121671P Topamax 100 Tablets 100mg Topiramate 100mg Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1156 BRU14121672NP Duratears Ocular Lubricant Ointment

Mineral Oil 30.0mg/g, Anhydrous liquid lanolin 30.0mg/g and white petrolatum q.s. ad 1g

S.A. Alcon-Couvreur N.V., Belgium

Hongkiat Trading & Co 19 May 2015 till 18 May 2020

GSL

1157 BRU14121673P Eprex® 40,000 Prefilled Syringes 40,000iu/1ml

Epoetin alfa 40,000IU/ml Vetter Pharma-Fertigung GmbH & Co. KG, Germany; Cilag AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1158 BRU14121674P Milosec Capsule 20mg Omeprazole 20mg The United Drug (1966) Co. Ltd., Thailand

Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

POM

1159 BRU14121675P Ziagen Oral Solution Abacavir (as Abacavir Sulfate) 20mg/ml GlaxoSmithKline Inc., Canada Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1160 BRU14121677P Pataday Olopatadine Ophthalmic Solution 0.2%

Olopatadine hydrochloride 2.22mg (eq. to Olopatadine 2mg (0.2%)

Alcon Laboratories, Inc., USA Medipharm Sdn Bhd 19 May 2020 till 18 May 2025

POM

1161 BRU14121681NP Strepsils Strawberry Sugar Free Children Lozenge

Amylmetacresol 0.6mg; 2.4-Dichlorobenzyl Alcohol 1.2mg

Reckitt Benckiser Healthcare International Limited, UK

Syarikat Aliaa Sdn Bhd 19 May 2020 till 18 May 2025

GSL

BDMCA/RMP/1220 Page 79 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1162 BRU14121682P Axcel Sodium Fusidate 250 Tablet

Sodium Fusidate (Micronized) 250mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

POM

1163 BRU14121683P Pencor 1mg tablet Doxazosin Mesylate (eq. to Doxazosin 1mg)

Unison Laboratories Co., Ltd, Thailand

K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1164 BRU14121684P Pencor 2mg tablet Doxazosin Mesylate (eq. to Doxazosin 2mg)

Unison Laboratories Co., Ltd, Thailand

K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1165 BRU14121685P Pencor 4 Tablet Doxazosin Mesylate (eq. to Doxazosin 4mg)

Unison Laboratories Co., Ltd, Thailand

K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1166 BRU14121686P Decan Injection 2mg/ml Dexamethasone Sodium Phosphate 2.2mg (eq. to Dexamethasone Phosphate 2mg)

Yung Shin Pharmaceutical Ind. Co., Ltd, Taiwan, R.O.C.

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1167 BRU14121687P Primodil-10 Tablet Amlodipine Besilate 13.87mg (eq. to Amlodipine 10mg)

Medley Pharmaceuticals Limited, India

Medicorp Sdn Bhd 19 May 2015 till 18 May 2020

POM

1168 BRU14121690P Seladin 500mg tablet Naproxen 500mg Y.S.P. Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1169 BRU14121691P Driminate 50mg Suppository Dimenhydrinate 50mg Y.S.P. Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

P

1170 BRU14121695P Axcel Fungicort Cream Miconazole nitrate 2%w/w; Hydrocortisone 1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

P

1171 BRU14121698P Edurant Film-Coated 25mg tablet

Rilpivirine (as hydrochloride) 25mg Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1172 BRU14121699P Invokana 300mg FCT Canagliflozin 300mg (as hemihydrate) Janssen-Cilag SpA, Italy Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1173 BRU14121700P Amlodipine Tablet 10mg Amlodipine Tablet 10mg Jubilant Generics, Limited, India Asterix United (B) Sdn Bhd 19 May 2015 till 18 May 2020

POM

1174 BRU14121701P Borymycin Capsule 100mg Minocycline HCl 100mg Y.S.P., Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1175 BRU14121702NP Septi-Sol Solution Chlorhexidine Gluconate 20% Solution - 0.5% w/v; Ethanol 94% - 77% v/v

Pahang Pharmacy Sdn Bhd, Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

GSL

1176 BRU14121703P Atoris Film-coated Tablet 20mg

Atorvastatin (as calcium) 20mg KRKA, d.d., Slovenia K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1177 BRU14121704NP Nutrilite Glucosamine HCl Capsule 375mg

Glucosamine HCl 375mg Pharmaniaga Manufacturing Berhad, Malaysia

Amway Sdn Bhd 19 May 2015 till 18 May 2020 (PL extended to 18 Nov 2020)

GSL

1178 BRU14121705P; BRU14121705PS2

Ultibro Breezhaler 110/50 mcg Inhalation Powder Hard Capsule

Indacaterol (as maleate) 110mcg (143 mcg); Glycopyrronium (as bromide) 50mcg (63 mcg)

Novartis Pharma Stein AG, Switzerland; Novartis Farmaceutica, SA, Barcelona, Spain (S2) [primary and secondary packaging: Novartis Farmaceutica, SA, Barcelona, Spain]

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 80 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1179 BRU15011710P Klerimed 250mg FC Tablets Clarithromycin 250mg (as anhydrous) Medochemie Ltd., Cyprus Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1180 BRU15011711P DiSuf-B Cream Fusidic acid (micronized) 2.0% w/w & Betamethasone 0.1%w/w (as valerate)

Hovid Bhd, Malaysia G & H Trading Company 19 May 2020 till 18 May 2025

POM

1181 BRU15011714P Ospamox 250mg/5ml granules for suspension

Amoxicillin 250mg (as trihydrate 287mg)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1182 BRU15011716P Ospamox 500mg Film-coated Tablet

Amoxicillin 500mg (as trihydrate 574mg)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1183 BRU15011722P T3 Ada Gel 0.1% Adapalene 0.1% Hoe Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

POM

1184 BRU15011723P Clarimycin Film Coated Tablet 250mg

Clarithromycin 250mg Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1185 BRU15011724P Forteo Injection 20mcg/80mcl Each ml contains 250mcg of Teriparatide (recombinant of human parathyroid hormone (1-34) [rhPTH (1-34)])

Lilly France SAS, France Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1186 BRU15011727P Bactigen Eye Drops 0.3% Gentamicin 0.3% (as Gentamicin Sulphate)

FDC Limited, India K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1187 BRU15011728P Hexaxim Suspension for Injection

Per dose (0.5ml):Dipththeria toxoid 30 Lf (≥ 20IU), Tetanus toxoid 10 Lf (≥ 40IU), Bordetella pertussis antigens: Pertussis toxoid 25µg, Filamentous haemagglutinin 25µg, Polio Virus (Inactivated): Type 1 (Mahoney) 40 DU, Type 2 (MEF-1) 8 DU, Type 3 (Saukett) 32 DU, Hepatitis B surface antigen 10 µg, Haemophilus influenzae tybe b polysaccharide (Polyribosylribitol phosphate) . 12µg, conjugated to Tetanus protein (PRP-T) 22-36µg

Sanofi Pasteur Marcy I’Etoile (MLE), France; Sanofi Pasteur Val de Reuil, France; Sanofi Pasteur SPA, Italy

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1188 BRU15011730PS1;BRU15011730PS3

Bridion Solution for Injection 100mg/ml

Sugammadex 100mg/ml N.V. Organon, The Netherlands (S1); Patheon Manufacturing Services LLC, USA (S3)

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1189 BRU15011732NP Strepsils Soothing Honey & Lemon Lozenge

Amylmetacresol 0.6ml; 2,4-Dichlorobenzyl alcohol 1.2mg

Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited, Thailand

Syarikat Aliaa Sdn Bhd 19 May 2020 till 18 May 2025

GSL

BDMCA/RMP/1220 Page 81 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1190 BRU15011733NP Strepsils Max Triple Action Hexylresorcinol 2.4mg Reckitt Benckiser Healthcare International Limited., Nottingham NG90 2DB, UK (Manufacturer)Reckitt Benckiser Healthcare Manufacturing (Thailand) Limited65 Moo 12, Lardkrabang-Bangplee Road, Bangplee,Samutprakam 10540 Thailand (Repacker)

Syarikat Aliaa Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1191 BRU15011734P Implanon NXT Implant 68mg Etonogestrel 68mg N.V. Organon, The Netherlands Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1192 BRU15011735PS2 Stocrin Tablet 200mg Efavirenz 200mg Zhejiang Huahai Pharmaceutical Co. Ltd., China

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1193 BRU15011736PS2 Stocrin Tablet 600mg Efavirenz 600mg Zhejiang Huahai Pharmaceutical Co. Ltd., China

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1194 BRU15011738NP Bactidol Mouthwash Hexetidine 0.1% w/v Interphill Laboratories Inc., Philippines

DCH Auriga (Borneo) Sdn Bhd 19 May 2020 till 18 May 2021

GSL

1195 BRU15011743P Pharmaniaga Germacid Cream 2%

Fusidic acid 2.0% w/w Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

POM

1196 BRU15011744P Extraneal Peritoneal Dialysis Solution 75g/l (2L Ultrabag)

Each 100ml contains Icodextrin 7.5g, Sodium Chloride 538mg, Sodium lactate 448mg, Calcium chloride dihydrate 25.7mg and Magnesium Chloride Hexahydrate 5.08mg

Baxter Healthcare SA., Singapore Branch

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1197 BRU15011745P Seladin 250mg tablet Naproxen 250mg Y.S.P Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1198 BRU15011746NP Vitalipid N Adult 1ml contains: Vitamin A 330IU (as retinoyl palmitate 99mg), Ergocalciferol 0.5mg(»Vitamin D2 20IU), All-rac-a-Tocopherol 0.91mg(»Vitamin E 1IU), Phytomenadione (Vitamin K1) 15mg

Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1199 BRU15011747NP Vitalipid N Infant 1ml contains: Vitamin A 230IU (as retinoyl palmitate 69mg), Ergocalciferol 1.0mg(»Vitamin D2 40IU), All-rac-a-Tocopherol 0.64mg(»Vitamin E 0.71IU), Phytomenadione (Vitamin K1) 20mg

Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 82 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1200 BRU15011749P Caslot 12.5mg tablet Carvedilol 12.5mg Ranbaxy (Malaysia) Sdn. Bhd., Malaysia

G & H Trading Company 19 May 2015 till 18 May 2020

POM

1201 BRU15011750NP Prismasol BO Each 1000ml contains (before reconstitution): Calcium chloride dihydrate 5.145g, Magnesium chloride hexahydrate 2.033g, Lactic acid 5.4g, Sodium chloride 6.45g & Sodium bicarbonate 3.09g

Bieffe Medital S.p.A., Italy Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1202 BRU15021754P Cernevit Multivitamin Powder for Injection

Each vial contains: Retinol palmitate (VitaminA) 3500 IU, Cholecalciferol (Vitamin D3) 220 IU, DL alpha tocopherol (Vitamin E) 10.2 mg, Ascorbic acid (Vitamin C) 125mg, Cocarboxylase tetrahydrate (Vitamin B1) 5.8mg, Riboflavin sodium phosphate dehydrate (Vitamin B2) 5.67mg, Pyridoxine hydrochloride (Vitamin B6) 5.5mg, Cyanocobalamin (Vitamin B12) 0.006mg, Folic acid 0.414mg, Dexpanthenol 16.15mg, Biotin 0.069mg, Nicotinamide 46mg

Baxter SA, Belgium Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1203 BRU15021755P Baneocin Ointment Bacitracin Zinc 250IU/1g; Neomycin Sulphate 5000 IU (5mg)/1g

P & G Health Austria GmbH & Co. OG, Werk Spittal, Austria

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1204 BRU15021757P Simponi Solution for Injection 50mg/0.5ml

Golimumab 50mg/0.5ml Baxter Pharmaceutical Solutions LLC, USA (Repacker & additional site to manufacture Pre-filled Syringe (PFS).- Cilag AG, Switzerland)

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1205 BRU15021760PS1 & BRU15021760PS2

Insulatard 100IU/ml Suspension for Injection (vial)

1ml of suspension contain 100IU (3.5g) of insulin

Novo Nordisk A/S, Denmark (S1); Novo Nordisk Production SAS, France (S2)

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1206 BRU15021761P Covapril Tablet 4mg Perindopril Erbumine Duopharma Manufacturing (Bangi) Sdn Bhd.

K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1207 BRU15021762P Axcel Amlodipine 5mg Tablet Amlodipine Besylate equivalent to Amlodipine 5mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

POM

1208 BRU15021764P Miostat Intraocular Solution Carbachol 0.1mg/ml Alcon Research LLC. , USA Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1209 BRU15021765NP NutrIflex Lipid Plus 1 unit consists of Amino Acid Solution; Glucose Solution; Lipid Emulsion* (For Detailed Formulation referred to Dossier)

B.Braun Melsungen AG, Germany

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 83 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1210 BRU15021766P Neulastim Pre-filled Syringe 6mg/0.6ml

Pegfilgrastim 6mg/0.6ml Amgen manufacturing Limited (AML), Puerto Rico, United States

Medipharm Sdn Bhd 19 May 2020 till 18 May 2025

POM

1211 BRU15021767P Bacitracin-N Ointment Bacitracin Zinc 12.5mg (potency) (Equivalent to Bacitracin Zinc 500 units); Polymyxin B Sulfate 0.83mg (potency) (Equivalent to Polymyxin B Sulfate 5,000 units); Neomycin Sulfate 3.5mg (potency)

Y.s.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1212 BRU15021768P Exelon Patch 15 Rivastigmine base 27mg / 15cm2 (In vivo release rate 13.3mg/24h)

LTS Lohmann Therapie-Systeme AG, Germany

Medipharm Sdn Bhd 19 May 2020 till 18 May 2025

POM

1213 BRU15021769NP Zellox-II, Double Strength Liquid Antacid

Per 10ml - Aluminium Hydroxide 800mg; Magnesium Hydroxide 800mg; Simethicone 60mg

Hoe Pharmaceuticals Sdn Bhd Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

GSL

1214 BRU15021770P Bonjela Gel 15g tube Choline Salicylate 8.714% & Cetalkonium chloride 0.01%

Reckitt Benckiser Healthcare (UK) Ltd., UK

Syarikat Aliaa Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1215 BRU15021771P Gilenya 0.5mg hard capsule Fingolimod 0.5mg (corresponding to 0.56mg Fingolimod Hydrochloride)

Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1216 BRU15021772P Presolin 150 tablet Irbesartan 150mg Unison Laboratories Co. Ltd., Thailand

K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1217 BRU15021773P Presolin 300 tablet Irbesartan 300mg Unison Laboratories Co. Ltd., Thailand

K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1218 BRU15021774P Tracidol Injection 50mg/ml Tramadol Hydrochloride 50mg/ml Y.S.P. Industries (M) Sdn Bhd Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1219 BRU15021776P Apo-Risperidone 2mg tablet Risperidone 2mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

POM

1220 BRU15021777P Apo-Megestrol 160mg tablet Megestrol acetate 160mg Apotex Inc, Canada Medicorp Sdn Bhd 19 May 2020 till 18 May 2025

POM

1221 BRU15021779P Trajenta Duo 2.5mg/500mg FCT tablet

Linagliptin 2.5mg; Metformin hydrochloride 500mg

Boehringer Ingelheim GmbH and Co. KG., Germany

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1222 BRU15021780P Trajenta Duo 2.5mg/850mg FCT

Linagliptin 2.5mg; Metformin hydrochloride 850mg

Boehringer Ingelheim GmbH and Co. KG., Germany

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1223 BRU15021781P Trajenta Duo 2.5mg/1000mg film-coated tablets

Linagliptin 2.5mg; Metformin hydrochloride 1000mg

Boehringer Ingelheim GmbH and Co. KG., Germany

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1224 BRU15021783P Acustop Cataplasma Flurbiprofen 40mg Green Cross Corporation, Korea Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1225 BRU15021784P Toviaz 4mg prolonged-release tablet

Fesoterodine fumarate equivalent to 3.1mg fesoterodine

Aesica Pharmaceuticals GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1226 BRU15021785P Toviaz 8mg prolonged-release tablet

Fesoterodine fumarate equivalent to 6.2mg fesoterodine

Aesica Pharmaceuticals GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 84 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1227 BRU15021786P Giotrif 20mg film-coated tablets (Afatinib 20mg)

Afatinib (as dimaleate) 20mg Boehringer Ingelheim Pharma GmbH and Co. KG., Germany

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1228 BRU15021787P Giotrif 30mg film-coated tablets (Afatinib 30mg)

Afatinib (as dimaleate) 30mg Boehringer Ingelheim Pharma GmbH and Co. KG., Germany

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1229 BRU15021788P Giotrif 40mg film-coated tablets (Afatinib 40mg)

Afatinib (as dimaleate) 40mg Boehringer Ingelheim Pharma GmbH and Co. KG., Germany

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1230 BRU15021789P Giotrif 50mg film-coated tablets (Afatinib 50mg)

Afatinib (as dimaleate) 50mg Boehringer Ingelheim Pharma GmbH and Co. KG., Germany

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1231 BRU15021793NP SMOFlipid 20% Emulsion for Infusion

1000ml contain: Soya-bean oil, refined 60 g, Medium-chain triglycerides 60 g, Olive oil, refined 50 g, Fish oil, rich in omega-2- acids 30 g

Fresenius Kabi Austria GmbH, Austria

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1232 BRU15021794NP Aminoven 10% Isoleucine 5.00g/L; Leucine 7.4g/L; Lysine acetate= Lysine 9.31g/L; Methionine 4.3g/L; Phenylalanine 5.1g/L; Threonine 4.4g/L; Tryptophan 2.0 g/L; Valine 6.2 g/L; Arginine 12.0g/L; Histidine 3.0 g/L, Alanine 14.0 g/L, Glycine 11.0 g/L; Proline 11.2 g/L; Serine 6.5g/L; Tyrosine 0.4g/L; Taurine 1.0g/L.

Fresenius Kabi Austria GmbH, Austria

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1233 BRU15021795P Ceflour CFT 250mg Cefuroxime (as Cefuroxime Axetil) 250mg

Yung Shin Pharmaceutical Ind. Co. Ltd., Republic of China

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1234 BRU15021796P Montelair 10mg film-coated tablet

Montelukast (as Montelukast Sodium) 10mg

Hovid Bhd., Malaysia G & H Trading Company 19 May 2020 till 18 May 2025

POM

1235 BRU15021797P Amlibon 10mg tablet Amlodipine (as Amlodipine Besilate) 10mg

Lek Pharmaceuticals D.D., Solvenia

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1236 BRU15021798NP Dianeal Low Calcium (2.5MEq/L) Peritoneal Dialysis Solution with 4.25% Dextrose (2L Ultrabag)

Each 100ml contains: Dextrose Hydrous 4.25g; Sodium Chloride 538mg; Sodium Lactate 448mg; Calcium Chloride dihydrate 18.3mg; and Magnesium Chloride Hexhydrate 5.08mg

Baxter Healthcare SA., Singapore Branch

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1237 BRU15021799NP Dianeal Low Calcium (2.5MEq/L) Peritoneal Dialysis Solution 2.5% Dextrose (2L Ultrabag and 2.5L Ultrabag)

Each 100ml contains: Dextrose Hydrous 2.5g; Sodium Chloride 538mg; Sodium Lactate 448mg; Calcium Chloride dihydrate 18.3mg; and Magnesium Chloride Hexhydrate 5.08mg

Baxter Healthcare SA., Singapore Branch

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

GSL

BDMCA/RMP/1220 Page 85 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1238 BRU15021800NP Dianeal Low Calcium (2.5MEq/L) Peritoneal Dialysis Solution 1.5% Dextrose (2L Ultrabag and 2.5L Ultrabag)

Each 100ml contains: Dextrose Hydrous 1.5g; Sodium Chloride 538mg; Sodium Lactate 448mg; Calcium Chloride dihydrate 18.3mg; and Magnesium Chloride Hexhydrate 5.08mg

Baxter Healthcare SA., Singapore Branch

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1239 BRU15021801NP CALACTATE TABLET 300MG Calcium Lactate pentahydrate 300mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2020 till 18 May 2025

GSL

1240 BRU15021802P Xylid 250mg tab Cefuroxime Axetil 250mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

POM

1241 BRU15021803P Colospan 10mg sugar coated tablet

Hyoscine Butylbromide 10mg Hovid Bhd, Malaysia G & H Trading Company 19 May 2020 till 18 May 2025

POM

1242 BRU15021805P Serenata 50mg Tablet Sertraline hydrochloride 56mg equivalent to Sertraline 50mg

Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 19 May 2020 till 18 May 2025

POM

1243 BRU15031809P Moxiclav Forte Dry Powder for Oral Suspension 312.5mg/5ml

Amoxicillin (as trihydrate) 250mg & Clavulanic acid 62.5mg

Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2020 till 18 May 2025

POM

1244 BRU15031810P Moxiclav 625mg Tablets Amoxicllin trihydrate (574mg) 500mg; clavulanate potassium microcrystalline cellulose (297.8mg) eq. to clavulanic acid 125mg

Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2020 till 18 May 2025

POM

1245 BRU15031811P Zemplar Injection Paricalcitol 5mcg/ml Avara Liscate Pharmaceutical Services S.p.A. [ secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1246 BRU15031812P Lamotrix 100mg Tablets Lamotrigine 100mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2020 till 18 May 2025

POM

1247 BRU15031813P Lamotrix 50mg Tablets Lamotrigine 50mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 86 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1248 BRU15031814P NimenrixTM (Meningococcal polysaccharide serogroups A,C,W-135, Y) Vaccine

MenAAH-TT-conjugate (Mean TT/PS ratio:3) 5mcg PSA~15mcg TT, MenCAH-TT-conjugate (Mean TT/PS ratio:3) 5mcg PSC~15mcg TT, MenW-TT-conjugate (Mean TT/PS ratio:1.5) 5mcg PSW~7.5mcg TT, MenY-TT-conjugate (Mean TT/PS ratio:1.3) 5mcg PSY~6.5mcg TT

Glaxosmithkline Biologicals s.a., Rixensart, Belgium; GlaxoSmithKline Biologicals, Branch of SmithKline Beecham Pharma GmbH & Co. KG., DresdenGermany (diluent Ampoule); Delpharm Tours, Chambray-lès-ToursFrance (Diluent ampoule); GlaxoSmithKline Biologicals SA, Rixensart Belgium (diluent PFS); Catalent Belgium SA, Brussels, Belgium (diluent PFS); GlaxoSmithKline Biologicals S.A. , Wavre Belgium (Additional facility for formulation); Pfizer Manufacturing Belgium NV, Belgium (additional secondary packaging site)

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1249 BRU15031816P Cialis 5mg Tablet Tadalafil 5mg Lilly del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1250 BRU15031817P Cialis 20mg Tablet Tadalafil 20mg Lilly del Caribe Inc., Puerto Rico Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1251 BRU15031818NP Tempol Tablet 500mg Paracetamol Tablet 500mg Duopharma (M) Sdn. Bhd., Malaysia

Hongkiat Trading & Company 19 May 2020 till 18 May 2025

P

1252 BRU15031820NP SmofKabiven Peripheral Emulsion for Infusion

1 unit consists of Amino Acid Solution; Glucose Solution; Lipid Emulsion (For detailed formulation referred to dossier)

Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1253 BRU15031821P Ometac capsule 20mg Omeprazole 20mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd. 19 May 2015 till 18 May 2020

POM

1254 BRU15031823P ADVATE 500IU Powder and Solvent for Solution for Injection

Octocog alfa (recombinant human coagulation factor VIII)

1) Baxalta Manufacturing Sarl, Switzerland (DP manufacturer); 2) Siegfried Hameln GmbH, Germany (Sterile Water for Injection (Diluent) manufacturer)

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 87 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1255 BRU15031824NP Livovid Forte Capsule Lecithin soya bean (300mg phosphatidyl choline) 858.0mg, Thiamine hydrochloride (4.7mg vitamin B1) 6mg, Riboflavin 6mg, Pyridoxine hydrochloride (4.93mg of vitamin B6) 6mg, Cyanocobalamin 0.006mg, Nicotinamide 30mg, dl-alpha-tocopherol acetate 6IU

Hovid Bhd., Malaysia G&H Trading Company 19 May 2020 till 18 May 2025

GSL

1256 BRU15031825P Saizen® Liquid 12mg (8mg/ml) Somatropin 12mg/1.5ml (recombinant human growth hormone)

Merck Serono S.p.A., Italy G&H Trading Company 19 May 2020 till 18 May 2025

POM

1257 BRU15031826P Saizen® Liquid 6mg (5.83mg/ml)

Somatropin 6mg/1.03ml (recombinant human growth hormone)

Merck Serono S.p.A., Italy G&H Trading Company 19 May 2020 till 18 May 2025

POM

1258 BRU15031827P Torpezil Tablets 10mg Donepezil hydrochloride 10mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn. Bhd. 19 May 2020 till 18 May 2025

POM

1259 BRU15031828P Torpezil Tablets 5mg Donepezil hydrochloride 5mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn. Bhd. 19 May 2020 till 18 May 2025

POM

1260 BRU15031830NP Gaviscon Liquid Sachet Each 10ml contains: Sodium alginate 500mg, Sodium bicarbonate 267mg and Calcium carbonate 160mg

Reckitt Benckiser Healthcare (UK) Ltd., UK

Syarikat Aliaa Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1261 BRU15031831NP Fisherman’s Friend Sugar-Free Apple & Cinnamon Lozenges

Menthol 4.025mg DCH Contract Manufacturing Sdn Bhd, Malaysia

Kingston Beverage & Creamery Sdn. Bhd.

19 May 2020 till 18 May 2025

GSL

1262 BRU15031833NP Fisherman’s Friend Sugar-Free Lemon Lozenges

Menthol 4.6mg DCH Contract Manufacturing Sdn Bhd, Malaysia

Kingston Beverage & Creamery Sdn. Bhd.

19 May 2020 till 18 May 2025

GSL

1263 BRU15041834P Rotaqor 20mg film-coated tablet

Atorvastatin Calcium 20mg Lek Pharmaceuticals D.D., Slovenia

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1264 BRU15041835P Jakavi 20mg tablet Ruxolitinib (as phosphate 26.40mg) 20mg

Novartis Pharma Stein, AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1265 BRU15041836P Jakavi 15mg tablet Ruxolitinib (as phosphate 19.8mg) 15mg

Novartis Pharma Stein, AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1266 BRU15041837P Jakavi 5mg tablet Ruxolitinib (as phosphate 6.6mg) 5mg Novartis Pharma Stein, AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1267 BRU15041839P Archifar 500mg powder for injection/infusion

Meropenem (as trihydrate) 500mg Medochemie Ltd, Cyprus Hong Kiat Trading & Co. 19 May 2020 till 18 May 2025

POM

1268 BRU15041840P Ciproflo 2mg/ml solution for IV infusion

Ciprofloxacin 2mg/ml (as hydrochloride)

Sin Guan Chem. Ind. Co. Ltd., Republic of China

K-Seri Pharma Sdn. Bhd. 19 May 2020 till 18 May 2025

POM

1269 BRU15041841P Omezole 20mg capsule Omeprazole 20mg Hovid Bhd., Malaysia G & H Trading Company 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 88 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1270 BRU15041842P B-Mycin cream Betamethasone dipropionate 0.643mg (eq. to 0.5mg betamethasone); Gentamicin Sulfate 1mg (potency)

Y.S.P. Industries (M) Sdn. Bhd., Malaysia

Asterix United (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1271 BRU15041843P Mucodin syrup 250mg/5ml Carbocysteine 250mg/5ml Sunward Pharmaceutical Sdn. Bhd., Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

P

1272 BRU15041844P Pharmaniaga Loratadine tablet 10mg

Loratadine 10mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

P

1273 BRU15041845P Curam 1000mg tablet Amoxycillin 875 (as trihydrate); clavulanic acid 125mg (as potassium clavulanate)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1274 BRU15041846P Vancotex Injection 500mg Vancomycin (as hydrochloride) 500mg Fisiopharma S.r.L., Italy K-Seri Pharma Sdn. Bhd. 19 May 2020 till 18 May 2025

POM

1275 BRU15041847P Sunadine tablet 10mg Loratadine 10mg Sunward Pharmaceutical Sdn. Bhd., Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

P

1276 BRU15041848NP Soluvit N Powder for Solution for Infusion

Thiamine mononitrate 3.1mg (corresponding to vitamin B1 2.5mg); Riboflavine sodium phosphate 4.9mg (corresponding to vitamin B2 3.6mg);Nicotinamide 40mg; Pyridoxine hydrochloride 4.9mg (corresponding to vitamin B6 4.0mg); Sodium panthothenate 16.5mg (corresponding to pantothenic acid 15.0mg); Sodium ascorbate 113mg (corresponding to Vitamin C 100mg); Biotin 60mcg; Folic acid 0.40mg; cyanocobalamin 5.0mcg

Sino Swed Pharmaceutical Corp. Ltd., China

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1277 BRU15041849NP SW Folic Acid Tablet 5mg Folic acid 5mg Sunward Pharmaceutical Sdn. Bhd., Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

P

1278 BRU15041850P Estelle-35 tablet Cyproterone acetate 2mg; Ethinylestradiol 0.035mg

Douglas Manufacturing Limited, New Zealand

G & H Trading Company 19 May 2020 till 18 May 2025

POM

1279 BRU15041851NP Cetomacrogol emulsifying ointment

Cetomacragol emulsifying wax 30% w/w; liquid paraffin 20%; white soft paraffin 50%

Hovid Bhd., Malaysia G & H Trading Company 19 May 2020 till 18 May 2025

GSL

1280 BRU15041852PS1/ BRU15041852PS2

Glucophage® XR 1000mg Extended-release tablet

Metformin (as hydrochloride 1000mg) 780mg

1. Merck Sante SAS, France; 2. Merck Healthcare KGaA, Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

BDMCA/RMP/1220 Page 89 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1281 BRU15041853NP Duofilm Solution Salicylic acid 16.7% w/w; lactic acid 16.7%

Delpharm Bladel B.V. Industrieweg, Bladel Netherlands

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

GSL

1282 BRU15041854NP Voluven Solution for Infusion 6%

Per 1000ml: Poly (O-2-hydroxyethyl) starch 60.0g; sodium chloride 9.00g

Frensius Kabi Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 19 May 2020 till 18 May 2025

POM

1283 BRU15041859NP Fisherman’s Friend Sugar Free Mint Lozenges

Menthol 3.45mg DCH Contract Manufacturing Sdn Bhd, Malaysia

Kingston Beverage & Creamery Sdn Bhd

19 May 2020 till 18 May 2025

GSL

1284 BRU15041860NP Fisherman’s Friend Sugar Free Cherry Lozenges With Menthol 6.9mg

Menthol 6.9mg DCH Contract Manufacturing Sdn Bhd, Malaysia

Kingston Beverage & Creamery Sdn Bhd

19 May 2020 till 18 May 2025

GSL

1285 BRU15041861NP ChlorHex 5% Concentrate Solution

Chlorhexidine gluconate 5% w/v Pahang Pharmacy Sdn Bhd, Malaysia

G & H Trading Company 19 May 2020 till 18 May 2025

GSL

1286 BRU15041862P Salmax CR tablet 4mg Salbutamol sulphate 4mg Duopharma Manufacturing (Bangi) Sdn. Bhd., Malaysia

Hongkiat Trading & Co 19 May 2020 till 18 May 2025

POM

1287 BRU15051863NP SP Pharma Paracetamol Tablets 500mg

Paracetamol 500mg Simpor Pharma Sendirian Berhad, Brunei Darussalam

Simpor Pharma Sendirian Berhad

19 May 2020 till 18 May 2025

P

1288 BRU15051864NP Addamel™ N Concentrate for Infusion

1 mL contains: Chromic chloride 6 H2O 5.33 µg; Copper chloride 2 H2O 340 µg; Ferric chloride 6 H2O 540 µg; Manganese chloride 4 H2O 99 µg; Potassium iodide 16.6 µg; Sodium fluoride 210 µg; Sodium molybdate 2 H2O 4.85 µg; Sodium selenite anhydrous 6.90 µg; Zinc chloride 1.36 mg

Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

POM

1289 BRU15051867NP Kabiven Peripheral Emulsion for Infusion

1000ml of the mixture contain: Purified soybean oil 35g; Glucose (anhydrous) 68g; Alanine 3.3g; Arginine 2.4g; Aspartic acid 0.71g; Phenylalanine 1.6g; Glutamic acid 1.2g; Glycine 1.6g; Histidine 1.4g; Isoleucine 1.2g; Leucine 1.6g; Lysine 1.9g; Methionine 1.2g; Proline 1.4g; Serine 0.94g; Threonine 1.2g; Tryptophan 0.40g; Tyrosine 0.05g; Valine 1.5g; Sodium glycerophosphate (anhydrous) 1.0g; Calcium chloride 0.15g; Potassium chloride 1.2g; Magnesium sulphate 0.33g; Sodium acetate 1.0g

Fresenius Kabi AB, Uppsala, Sweden

Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

POM

BDMCA/RMP/1220 Page 90 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1290 BRU15051868NP Kabiven Emulsion for Infusion 1000ml of the mixture contain: Purified soybean oil 39g; Glucose (anhydrous) 97g; Alanine 4.7g;Arginine 3.3g; Aspartic acid 0.99g; Phenylalanine 2.3g; Glutamic acid 1.6g; Glycine 2.3g; Histidine 2.0g; Isoleucine 1.6g; Leucine 2.3g; Lysine 2.6g; Methionine 1.6g; Proline 2.0g; Serine 1.3g; Threonine 1.6g; Tryptophan 0.56g; Tyrosine 0.07g; Valine 2.1g; Sodium glycerophosphate (anhydrous) 1.5g; Calcium chloride 0.22g; Potassium chloride 1.7g; Magnesium sulphate 0.47g; Sodium acetate 1.4g

Fresenius Kabi AB, Uppsala, Sweden

Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

POM

1291 BRU15051869P Dopatab M250 Tablet Methyldopa 250mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2020 till 27 July 2025

POM

1292 BRU15051870P Fenagesic Tablet 250mg Mefenamic acid 250mg Sunward Pharmaceutical Pte Ltd., Singapore

G & H Trading Company 28 July 2020 till 27 July 2025

POM

1293 BRU15051871P Metta SR Tablets 500mg Metformin Hydrochloride USP 500mg Torrent Pharmaceuticals Ltd., Indrad, India

K-Seri Pharma Sdn Bhd 28 July 2020 till 27 July 2025

POM

1294 BRU15051872P Diamitex Tablet 80mg Gliclazide 80mg Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 28 July 2020 till 27 July 2025

POM

1295 BRU15051873NP Calamine Lotion Calamine BP 15% w/v Royce Pharma Manufacturing Sdn Bhd, Malaysia

SWL Biomed Sales & Services 28 July 2020 till 27 July 2025

GSL

1296 BRU15051874NP Fisherman’s Friend Original Lozenges

Menthol 10.35mg; Eucalyptus oil 1.73mg

Lofthouse of Fleetwood Limited, UK [repacker: DCH Contract Manufacturing Sdn Bhd, Malaysia]

Kingston beverage & Creamary Sdn Bhd

28 July 2020 till 27 July 2025

GSL

1297 BRU15051876NP Fisherman’s Friend Sugar Free Original Lozenges

Menthol 9.2mg DCH Contract Manufacturing Sdn Bhd, Malaysia

Kingston beverage & Creamary Sdn Bhd

28 July 2020 till 27 July 2025

GSL

1298 BRU15051878P Loratyn-10 Loratadine 10mg Hovid Bhd., Malaysia G & H Trading Company 28 July 2020 till 27 July 2025

P

1299 BRU15051879P Candazole V Single Dose Cream 10% w/w

Clotrimazole 10% w/w HOE Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 28 July 2020 till 27 July 2025

P

1300 BRU15061880P Keppra® Oral Solution 100mg/ml

Levetiracetam 10mg/ml NextPharma SAS., France Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

POM

1301 BRU15061881P Norditrophin NordiFlex Inejction 5mg/1.5ml Pre-filled Pen, Solution for Injection

Somatropin (rDNA) 3.3mg/ml Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

POM

BDMCA/RMP/1220 Page 91 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1302 BRU15061882P Aceprin 100mg tablet Aspirin 100mg Hovid Bhd, Malaysia G & H Trading Company 28 July 2020 till 27 July 2025

POM

1303 BRU15061883NP Povidone Iodine solution 10% w/v

Povidone Iodine 10% w/v Royce Pharma Manufacturing Sdn. Bhd., Malaysia

SWL Biomed Sales & Services 28 July 2020 till 27 July 2025

GSL

1304 BRU15061884P Pharmaniaga Cephalexin Suspension 250mg

Cephalexin (as Cephalexin Anhydrous) 250mg/5mL

Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 28 July 2020 till 27 July 2025

POM

1305 BRU15061885P Zorax Suspension 200mg/5ml Aciclovir 200mg/5ml Sunward Pharmaceutical Pte. Ltd., Singapore

G & H Trading Company 28 July 2020 till 27 July 2025

POM

1306 BRU15061886P Ganaton 50mg tablet Itopride hydrochloride 50mg Abbott Japan Co. Ltd., Japan Zuellig Pharma (B) Sdn Bhd 28 July 2015 till 27 July 2020

POM

1307 BRU15061887NP PVP Iodine Solution Povidone-Iodine 10% w/v (equivalent to 1% available Iodine)

Dynapharm (M) Sdn. Bhd., Malaysia

Medicorp Sdn Bhd 28 July 2020 till 27 July 2025

GSL

1308 BRU15061888P Herceptin Powder for Injection 440mg/vial

Trastuzumab 440mg Genentech Inc., California, USA; Genentech Inc., Oregon, USA; [F. Hoffmann-La Roche Ltd, Kaiseraugst, Switzerland (Manufacturer and packaging site for Solvent); F. Hoffmann-La Roche Ltd, Kaiseraugst, Switzerland (Secondary packaging of finished product)]

MediPharm Sdn Bhd 28 July 2020 till 27 July 2025

POM

1309 BRU15061889P Azoren 20mg/5mg Film-Coated Tablet

Olmesartan medoxomil 20mg and Amlodipine (as amlodipine besylate) 5mg

Daiichi Sankyo Europe GmbH, Germany [repacker: Pfizer Manufacturing Deutschland GmBH, Germany]

Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

POM

1310 BRU15061890P Azoren 40mg/10mg Film-Coated Tablet

Olmesartan medoxomil 40mg and Amlodipine (as amlodipine besylate) 10mg

28 July 2020 till 27 July 2025 Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

POM

1311 BRU15061891P Azoren 40mg/5mg Film-Coated Tablet

Olmesartan medoxomil 40mg and Amlodipine (as amlodipine besylate) 5mg

Daiichi Sankyo Europe GmbH, Germany [repacker: Pfizer Manufacturing Deutschland GmBH, Germany]

Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

POM

1312 BRU15061892P Perindosyl 4mg Tablet Perindopril tert-butylamine 4mg (eqv. to 3.338mg perindopril)

Lek Pharmaceuticals DD., Slovenia

Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

POM

1313 BRU15061893NP Mentholatum Deep Heating Rub

Methyl Salicylate 12.7% & Menthol 5.8%

The Mentholatum Co., Inc., USA Hamitan Marketing 28 July 2020 till 27 July 2025

GSL

1314 BRU15061894NP Oxy Cover Cream Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co. Ltd., Vietnam

Hamitan Marketing 28 July 2020 till 27 July 2025

GSL

1315 BRU15061896NP Hocodin Lozenge 250mcg Dequalinium chloride 250mcg Winwa Medical Sdn. Bhd., Malaysia

Medicorp Sdn. Bhd. 28 July 2020 till 27 July 2025

GSL

BDMCA/RMP/1220 Page 92 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1316 BRU15061897NP Gaviscon Advance Peppermint Sodium alginate 500mg/5mlPotassium bicarbonate 100mg/5ml

Reckitt Benckiser Healthcare (UK) Ltd., UK

Zuellig Pharma (B) Sdn Bhd 28 July 2020 till 27 July 2025

GSL

1317 BRU15071899P Cavumox 625mg Tablet Amoxicillin (as trihydrate) 500mg; Clavulanic acid (as potassium salt) 125mg

Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1318 BRU15071900NP Gaviscon Liquid Per 10ml - Sodium alginate 500mg; Sodium bicarbonate 267mg; Calcium carbonate 160mg

Reckitt Benckiser Healthcare (UK) Ltd, UK

Syarikat Aliaa Sdn Bhd 09 Dec 2020 till 08 Dec 2025

GSL

1319 BRU15071901P Zapine 100mg Tablet Clozapine100mg Taiwan Biotech Co. Ltd, Taiwan G & H Trading Company 09 Dec 2020 till 08 Dec 2025

POM

1320 BRU15071902P Alendronate Sandoz 70mg FCT Alendronic acid 70mg Lek Pharmaceuticals D.D., Ljubljana, Slovenia

Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1321 BRU15071903NP Chlorhex 4% antiseptic solution

Chlorhexidine gluconate 4% Pahang Pharmacy Sdn Bhd., Malaysia

G & H Trading Company 09 Dec 2020 till 08 Dec 2025

GSL

1322 BRU15071904P Resolor Film-coated Tablet 2mg

Prucalopride succinate 2.642mg eqv Prucalopride 2mg

Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1323 BRU15071905P Proglutrol 500 Extended Release Tablets

Metformin Hydrochloride 500mg Inventia Healthcare Ltd., India Medicorp Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1324 BRU15071906NP Gaviscon Double Action Liquid Per 10ml - Sodium Alginate 500mg; Sodium Bicarbonate 213mg; Calcium Carbonate 325mg

Reckitt Benckiser Healthcare (UK) Ltd, UK

Syarikat Aliaa Sdn Bhd 09 Dec 2020 till 08 Dec 2025

GSL

1325 BRU15071907NP Gaviscon Double Action Tablet Sodium Alginate 250mg; Sodium Bicarbonate 106.5mg; Calcium Carbonate 187.5mg

Reckitt Benckiser Healthcare (UK) Ltd, UK

Syarikat Aliaa Sdn Bhd 09 Dec 2020 till 08 Dec 2025

GSL

1326 BRU15071908P Daivobet Gel Calcipotriol (as monohydrate) 50mcg/g & betamethasone (as dipropionate) 0.5mg/g

LEO Laboratories Ltd., Ireland Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1327 BRU15071909NP Oxy 10 Lotion Benzoyl peroxide 10% w/w Rohto-Mentholatum (Vietnam) Co. Ltd., Vietnam

Hamitan Marketing 09 Dec 2020 till 08 Dec 2025

GSL

1328 BRU15071910NP Oxy 5 Lotion Benzoyl peroxide 5% w/w Rohto-Mentholatum (Vietnam) Co. Ltd., Vietnam

Hamitan Marketing 09 Dec 2020 till 08 Dec 2025

GSL

1329 BRU15071911P Hydrogen Peroxide Solution (6%)

Hydrogen Peroxide 6% w/v (equivalent to 20 volumes of available oxygen)

The Government Pharmaceutical Organization, Thailand

SWL Biomed Sales & Services 09 Dec 2020 till 08 Dec 2025

GSL

1330 BRU15081913NP Zentel Suspension 400mg/10ml

Albendazole 400mg/10ml Smithkline Beecham, Philippines Kingston Beverage & Creamery Sdn Bhd

09 Dec 2020 till 08 Dec 2025

GSL

1331 BRU15081914P Xalacom Eye Drops 1ml contains latanoprost 50 micrograms and timolol maleate 6.8mg (eq to 5mg timolol)

Pfizer Manufacturing Belgium NV, Belgium

Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1332 BRU15081916P Unihepa 5000IU/ml Injection (5ml vial)

Heparin sodium 5000IU/ml Duopharma (M) Sdn Bhd., Malaysia

K-Seri Pharma Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

BDMCA/RMP/1220 Page 93 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1333 BRU15081917P Olmetec 40 Tablet Olmesartan Medoxomil 40mg Daiichi Sankyo Europe GmbH, Germany; Pfizer Manufacturing Deutschland GmbH, Germany (primary and secondary packaging site)

Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1334 BRU15081918P Olanzapine Orodispersible Tablets 5mg

Olanzapine 5mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020

POM

1335 BRU15081919P Olanzapine Orodispersible Tablets 10mg

Olanzapine 10mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 09 Dec 2015 till 08 Dec 2020

POM

1336 BRU15081920P Metrogyl Injection 5mg/ml Metronidazole 500mg/100mL Unique Pharmaceutical Laboratories, India

K-Seri Pharma Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1337 BRU15081921P Pharmaniaga Dermapro Ointment 0.05% w/w

Clobetasol propionate 0.05% w/w Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 09 Dec 2020 till 08 Dec 2025

POM

1338 BRU15081922P Olmetec Plus 40/12.5mg Film-Coated Tablet

Olmesartan Medoxomil 40mg; Hydrochlorothiazide 12.5mg

Daiichi Sankyo Europe GmbH, Germany; Pfizer Manufacturing Deutschland GmbH, Germany (primary and secondary packaging site)

Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1339 BRU15081923P Risperdal Tablet 1mg Risperidone 1mg Janssen Cilag SPA, Italy [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1340 BRU15081924P Risperdal Tablet 2mg Risperidone 2mg Janssen Cilag SPA, Italy [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1341 BRU15081925P Apo-Clopidogrel Tablet 75mg Clopidogrel (as bisulfate) 75mg Apotex Inc. Canada, Canada Medicorp Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1342 BRU15081926NP Win-Aqueous Cream Emulsifying Wax 8%w/w; Liquid Paraffin; 5% w/w; White Soft Paraffin 13% w/w

Winwa Medical Sdn Bhd., Pulau Pinang, Malaysia

Medicorp Sdn Bhd 09 Dec 2020 till 08 Dec 2025

GSL

1343 BRU15091928P Acular Ophthalmic Solution 0.5%

Ketorolac Tromethamine 0.5% Allergan Pharmaceuticals Ireland, Ireland

MediPharm Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1344 BRU15091929P Dilantin capsule 30mg Phenytoin Sodium 30mg Pfizer Pharmaceuticals LLC, Vega Baja, USA (Pfizer Vega Baja)

Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1345 BRU15091930P Zymar (gatifloxacin ophthalmic solution) 0.3%

Gatifloxacin 0.3% Allergan Sales, United States MediPharm Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

BDMCA/RMP/1220 Page 94 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1346 BRU15091931P Klerimed 500mg Film-Coated Tablets

Clarithromycin 515mg (equivalent to anhydrous clarithromycin 500mg)

1. Medochmie Ltd (Factory AZ), Cyprus2. Medochmie Ltd (Central Factory), Cyprus

Hongkiat Trading & Company 09 Dec 2020 till 08 Dec 2025

POM

1347 BRU15091932P Gadovist Injection 1.0mmol/ml Prefilled syringe 5.0ml

Gadobutrol pure 604.72mg & Calcium sodium butrol 0.513mg

Bayer AG, Berlin, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1348 BRU15091933P Gadovist Injection 1.0mmol/ml

Gadobutrol pure 604.72mg & Calcium sodium butrol 0.513mg

Bayer Pharma AG, MÜllerstr. 178Bayer AG, MÜllerstraβe 178, Germany

Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1349 BRU15091935P Cardiprin 100 Tablet Aspirin 100mg Reckitt Benckiser Healthcare (UK),United Kingdom

Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1350 BRU15091936P Calact 300mg Tablets Calcium Lactate USP Eq. to Calcium Lactate Pentahydrate 300mg. Elemental Calcium 39mg (from Calcium lactate pentahydrate 300mg).

Unique Pharmaceutical Laboratories (A Division of J.B. Chemicals & Pharmaceuticals Limited), India.

K-Seri Pharma Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1351 BRU15091937NP Guafensin Syrup 20mg/ml Guaifenesin 20mg/ml Y.S.P. Industries (M) Sdn. Bhd., Malaysia

Asterix United (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1352 BRU15091939NP Hoe Zinc Cream Zinc Oxide 32% w/w HOE Pharmaceuticals Sdn. Bhd., Malaysia

G & H Trading Company 09 Dec 2020 till 08 Dec 2025

GSL

1353 BRU15091940P Pirimat Injection 10mg/ml (1ml ampoule)

Chlorpheniramine Maleate 10mg/m Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 09 Dec 2020 till 08 Dec 2025

POM

1354 BRU15091946P Axcel Bromhexine (Children) Elixir

Bromhexine Hydrochloride 4mg Kotra Pharma (M) Sdn Bhd., Malaysia

Medicorp Sdn Bhd. 09 Dec 2020 till 08 Dec 2025

P

1355 BRU15101947P Cetyrol 10mg Film-coated Tablet

Cetirizine dihydrochloride 10mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

P

1356 BRU15101948P Archifar 1g Powder for Solution for Injection/Infusion

Meropenem (as trihydrate) 1g Medochemie Ltd., Cyprus Hongkiat Trading & Co 09 Dec 2020 till 08 Dec 2025

POM

1357 BRU15101949P Antismine Syrup 2mg/5ml Chlorpheniramine maleate 2mg/5ml Winwa Medical Sdn Bhd., Malaysia

Medicorp Sdn Bhd 09 Dec 2020 till 08 Dec 2025

P

1358 BRU15101950P Respidon 2mg Tablets Risperidone 2mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1359 BRU15101951P Respidon 1mg Tablets Risperidone 1mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1360 BRU15101952NP Flexjoint 1500mg Powder Crystalline glucosamine sulphate 1884mg (equivalent to glucosamine sulphate 1500mg)

Winwa Medical Sdn Bhd., Malaysia

Medicorp Sdn Bhd 09 Dec 2020 till 08 Dec 2025

GSL

BDMCA/RMP/1220 Page 95 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1361 BRU15101954P Tystatin Oral Suspension Nystatin BP 100,000 units T.O. Chemicals (1979) Co. Ltd., Thailand

Medicorp Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1362 BRU15101955P Ezede Tablet 10mg Loratadine 10mg Xepa-Soul Pattinson (M) Sdn Bhd., Malaysia

Hongkiat Trading & Co 09 Dec 2020 till 08 Dec 2025

P

1363 BRU15101956P Pred Forte Sterile Ophthalmic Suspension 1%

Prednisolone acetate 1% w/v Allergan Pharmaceuticals Ireland, Mayo, Ireland

Medipharm Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1364 BRU15111957P Stivarga Tablet 40mg Regorafenib(40mg Regorafenib equivalent to 41.49mg Regorafenib monohydrate)

Bayer AG, Leverkusen, Germany Zuellig Pharma (B) Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1365 BRU15111958P A Scabs Lotion Permethrin 5.0% w/v HOE Pharmaceuticals Sdn. Bhd., Malaysia

G & H Trading Company 09 Dec 2020 till 08 Dec 2025

GSL

1366 BRU15111959P; BRU15111959PS2

Insugen-N (NPH) Insulin Injection, Isophane Ph. Eur. (Human Insulin rDNA origin) 100IU/ml

Biocon Limited, India; Biocon Sdn Bhd, Malaysia (S2)

K-Seri Pharma Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1367 BRU15111961NP Infusol® NS (Ampoule) Sodium chloride 0.9%w/v AIN Medicare Sdn. Bhd., Malaysia

Syarikat Pakatan Indah 09 Dec 2020 till 08 Dec 2025

GSL

1368 BRU15111962NP Infusol W (Sterilised Water for Injection BP)

Water for injection BP AIN Medicare Sdn. Bhd., Malaysia

Syarikat Pakatan Indah 09 Dec 2020 till 08 Dec 2025

GSL

1369 BRU15111963P Elan Forte Cream Tolnaftate 10mg/g; Chlorhexidine HCl 2mg/g

Y.S.P. Industries (M) Sdn. Bhd.,Malaysia

Asterix United (B) Sdn Bhd. 09 Dec 2020 till 08 Dec 2025

GSL

1370 BRU15111964P Valparin XR 500mg Tablet i) Sodium Valproate 333mgii) Valproic Acid 145mg (Both together correspond to sodium valproate 500mg)

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd., 09 Dec 2020 till 08 Dec 2025

POM

1371 BRU15111965P Axcel Betamethasone Cream Betamethasone 17-Valerate (micronized) equivalent to Betamethasone 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 09 Dec 2020 till 08 Dec 2025

POM

1372 BRU15111967P Cough-En Linctus Dextromethorphan Hydrobromide 15mg/5ml;Tripolidine Hydrochloride 1.25mg/5ml;Pseudoephedrine Hydrochloride 30mg/5ml

Xepa-Soul Pattinson (Malaysia) Sdn. Bhd., Malaysia

Hongkiat Trading & Company 09 Dec 2020 till 08 Dec 2025

POM

1373 BRU15121972PS1 & BRU15121972PS2

Varivax (refrigerated) Varicella Virus Vaccine Live (Oka / Merck) 1350PFU / 0.5ml

Merck Sharp & Dohme Corp., Pennsylvania USA (S1)ii) Merck Sharp and Dohme Corp., North Carolina, US (S2)

Zuellig Pharma (B) Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1374 BRU15121973P SW-Dexasone Tablet Dexamethasone 0.5mg Sunward Pharmaceutical Sdn Bhd., Singapore

G & H Trading Company 21 Jun 2021 till 20 Jun 2026 POM

1375 BRU15121974P Paracetamol Codeine Tablet Paracetamol 500mg and Codeine Phosphate 8mg

Sunward Pharmaceutical Pte. Ltd., Singapore

G & H Trading Company 21 Jun 2021 till 20 Jun 2026 POM

BDMCA/RMP/1220 Page 96 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1376 BRU15121975NP Mentholatum Deep Heat Sport Pain Relief Spray

Methyl Nicotinate 16mg/g; Glycol Salicylate 50mg/g; Methyl Salicylate 10mg/g; Ethyl salicylate 50mg/g

Ensign Labs Pty. Ltd., Australia Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL

1377 BRU15121976NP Mentholatum Deep Cold Ice Gel Therapy

Menthol 20g/g Mentholatum Australia Pty. Ltd., Australia

Hamitan Marketing 21 Jun 2016 till 20 Jun 2021 GSL

1378 BRU15121977NP Axcel Urea Cream Urea 10% w/w Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 GSL

1379 BRU15121979P Medocef 1g Powder for Solution for Injection or Infusion

Cefoperazone (as sodium) 1g Medochemie Ltd., Cyprus Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1380 BRU15121980NP Axcel Dexxon Lozenges Dequalinium Chloride 0.25mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 GSL

1381 BRU15121981P Oragel Pain Relief Choline Salicylate 9% w/w & Cetylpyridinium Chloride 0.05% w/w

Winwa Medical Sdn. Bhd., Malaysia

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 GSL

1382 BRU16011982NP; BRU16011982NPS2

0.9% Sodium Chloride Injection, USP

Sodium Chloride USP 0.9% Baxter Healthcare Corporation, USA; Baxter Healthcare Philippines Inc. (S2); Baxter Healthcare, Aibonito, Puerto Rico, USA

Zuellig Pharma (B) Sdn Bhd 21 Jun 2021 till 20 Jun 2026 GSL

1383 BRU16011983P Amlibon 5mg Tablet Amlodipine (as Amlodipine Besilate) 5mg

Lek Pharmaceuticals DD., Slovenia

Zuellig Pharma (B) Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1384 BRU16011985P Azukon MR 30mg Tablet Gliclazide 30mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1385 BRU16011986P Espran 10mg Tablet Escitalopram (as Oxalate) 10mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1386 BRU16011987P Zenalb 20% Human albumin 20%w/v Bio Product Lab, UK Medipharm Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1387 BRU16011989P Pharmaniaga Potassium Chloride 10% w/v Injection

Potassium Chloride 10% w/v Pharmaniaga Manufacturing Berhad, Malaysia

G&H Trading Company 21 Jun 2016 till 20 Jun 2021 POM

1388 BRU16011990P Gastografin Solution 1ml contains Sodium amidotrizoate 0.1g and Meglumine amidotrizoate 0.66g

Berlimed SA, Spain Zuellig Pharma (B) Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1389 BRU16011991P Rabotide Capsule 20mg (as enteric coated pellets)

Rabeprazole Sodium 20mg Inventia Healthcare Limited, India

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1390 BRU16011992P Pharmaniaga Gliclazide Tablet 80mg

Gliclazide 80mg Pharmaniaga Manufacturing Berhad, Malaysia

G&H Trading Company 21 Jun 2021 till 20 Jun 2026 POM

1391 BRU16011993NP Betadine Antiseptic Ointment Povidone-Iodine 10% w/w Pt. Mahakam Beta Farma, Indonesia

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1392 BRU16011994NP Betadine Feminine Wash with Douching Apparatus 10% w/v

Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

BDMCA/RMP/1220 Page 97 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1393 BRU16011995NP Betadine Feminine Wash Povidone-Iodine 10% w/v Pt. Mahakam Beta Farma, Indonesia

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 GSL

1394 BRU16011996NP Coxan Tablets 500mg Paracetamol 500mg Prime Pharmaceuticals Sdn Bhd., Malaysia

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 P

1395 BRU16011997P Soluwax Ear Drops Docusate sodium 0.5% w/v Hoe Pharmaceuticals Sdn Bhd., Malaysia

G&H Trading Company 21 Jun 2021 till 20 Jun 2026 GSL

1396 BRU16021998P; BRU16021998PS2

Insugen-R (NPH) Insulin Injection, Soluble Ph. Eur. (Insulin, Human of recombinant DNA origin) 100 IU/ml

Biocon Limited, India; Biocon Sdn Bhd, Malaysia (S2)

K-Seri Pharma Sdn Bhd 22 Jun 2021 till 20 Jun 2026 POM

1397 BRU16021999P Levetiracetam tablet 500mg Levetiracetam 500mg Jubilant Generics, Limited, India Axterix United (B) Sdn. Bhd 21 Jun 2016 till 20 Jun 2021 POM

1398 BRU16022000P Glimicron 80mg tablet Gliclazide 80mg HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2021 till 20 Jun 2026 POM

1399 BRU16022001NP Hovid-Liquid Paraffin Liquid Paraffin BP 100% HOVID Bhd, Malaysia G & H Trading Co 21 Jun 2021 till 20 Jun 2026 GSL

1400 BRU16022002NP Noxworm Suspension (chocolate) 400mg

Albendazole 200mg/5mL Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1401 BRU16022003P; BRU16022003PS2

Mircera pre-filled syringe 100mcg/0.3ml

Methoxy polyethylene glycol-epoetin beta 100mcg/0.3ml

Roche Diagnostics GmbH, Germany; F. Hoffmann-La Roche AG, Kaiseraugst, Switzerland (S2)

MediPharm Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1402 BRU16022006P Rocaltrol capsule 0.25mcg Calcitriol 0.25mcg Catalent Germany Eberbach GmbH, Germany for F.Hoffmann-La Roche Ltd., Switzerland

Hongkiat Trading & Company 21 Jun 2021 till 20 Jun 2026 POM

1403 BRU16022007P Adezio Oral Suspension Cetirizine Hydrochloride 1mg/ml Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 21 Jun 2021 till 20 Jun 2026 P

1404 BRU16022008P Zarin cream Miconazole nitrate 2%w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 21 Jun 2021 till 20 Jun 2026 GSL

1405 BRU16022010P Bena® Expectorant

Diphenhydramine hydrochloride 14mg/5ml and ammonium chloride 135mg/5ml

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 21 Jun 2021 till 20 Jun 2026 POM

1406 BRU16022011P Pantor 20 Pantoprazole (as sodium sesquihydrate) 20mg

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1407 BRU16022012P Pantor 40 Pantoprazole (as sodium sesquihydrate) 40mg

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1408 BRU16032013P Ceritec Film Coated Tablet 10mg

Cetirizine Hydrochloride 10mg Y.S.P. Industries (M) Sdn. Bhd., Malaysia.

Asterix United (B) Sdn Bhd 21 Jun 2021 till 20 Jun 2026 P

1409 BRU16032014P Tinazol Cream 2% (15g) Miconazole nitrate 2% w/w Hovid Bhd, Malaysia. G & H Trading Company 21 Jun 2021 till 20 Jun 2026 GSL

BDMCA/RMP/1220 Page 98 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1410 BRU16032015PS1 & BRU16032015PS2

M-M-R II® Vaccine Live, attenuated virus derived from Edmonston B strain of measles - 3.0 log TCID50, Live attenuated Jeryl LynnTM

strain of mumps - 4.1 log TCID50, Live, attenuated Wistar RA 27/3 strain of rubella - 3.0 log TCID50

1. Merck Sharp & Dohme Corp., Pennsylvania, USA, 2. Merck Sharp & Dohme Corp., North Carolina, U.S.A

Zuellig Pharma (B) Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1411 BRU16032016P; BRU16032016PS2

Insugen-30/70 (Biphasic) Insulin Injection, Biphasic Isophane Ph. Eur. (Insulin, Human recombinant DNA origin) 100 IU/ml

Biocon Limited, India; Biocon Sdn Bhd, Malaysia (S2)

K-Seri Pharma Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1412 BRU16032017P Natrixam 1.5mg/10mg modified-release tablet

Indapamide 1.5mg & Amlodipine 10mg (as besilate)

Les Laboratories Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1413 BRU16032018P Natrixam 1.5mg/5mg modified-release tablet

Indapamide 1.5mg & Amlodipine 5mg (as besilate)

Les Laboratories Servier Industrie, France

Zuellig Pharma (B) Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1414 BRU16032019P Levetiracetam 250mg tablet Levetiracetam 250mg Jubilant Generics Limited, India Asterix United (B)Sdn Bhd., 21 Jun 2016 till 20 Jun 2021 POM

1415 BRU16032020NP Mifuko Ointment Zinc Oxide 6% (w/w) and Salicylic acid 5% (w/w)

Winwa Medical Sdn Bhd, Malaysia.

Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1416 BRU16032021P Primodil 5 Tablet Amlodipine Besilate 6.94mg (equivalent to Amlodipine 5mg)

Medley Pharmaceuticals Ltd, India

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1417 BRU16032022P Oxair Film Coated Tablet 10mg

Montelukast Sodium 10.4mg (equivalent to Montelukast 10mg)

Y.S.P. Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 22 Jun 2021 till 20 Jun 2026 POM

1418 BRU16032023NP Bacidin Antiseptic Cream 1% w/w

Chlorhexidine Gluconate 1% w/w Xepa-soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 22 Jun 2021 till 20 Jun 2026 GSL

1419 BRU16032024P Axcel Oxymetazoline 0.05% Nasal Spray

Oxymetazoline Hydrochloride 0.05% w/v

Kotra Pharma (M) Sdn Bhd., Malaysia.

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 P

1420 BRU16042026NP Migrate Q10 Coenzyme Q10………….100mg; Lycopene………………….... 5mg; L-Arginine…………….…..100mg; Zinc Sulphate monohydrate (eq to Elemental zinc)..22.5mg; Piperine………………………..5mg; Sodium selenite (eq to Elemental selenium) ….70mcg

Goodman Pharmaceuticals, India.

MediBiotech 21 Jun 2016 till 20 Jun 2021 GSL

1421 BRU16042027NP Potassium Chloride Injectable Solution 10%

Potassium chloride 1g / 10ml DEMO SA Pharmaceutical Industry, Greece.

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

BDMCA/RMP/1220 Page 99 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1422 BRU16042028P Oratane 20mg Capsules Isotretinoin 20mg Swiss Caps AG, Switzerland, Contract Mfg. for Douglas Pharmaceuticals Limited, New Zealand.

K-Seri Pharma Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1423 BRU16042029P Oratane 10mg Capsules Isotretinoin 10mg Swiss Caps AG, Switzerland, Contract Mfg. for Douglas Pharmaceuticals Limited, New Zealand.

K-Seri Pharma Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1424 BRU16042030NP Osteoactiv 3 in 1 Joint Formula Powder

Glucosamine Hydrochloride 1000mg, Methylsulfonylmethane 1000mg, Chondroitin Sulphate Sodium 880.4mg (equivalent to 800mg chondroitin)

Winwa Medical Sdn. Bhd., Malaysia.

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 GSL

1425 BRU16042031NP Osteoactiv 3 in 1 Joint Formula Tablet

Glucosamine Hydrochloride 250mg, Methylsulfonylmethane 250mg, Chondroitin Sulphate Sodium 220mg (equivalent to 200mg chondroitin)

Winwa Medical Sdn. Bhd., Malaysia.

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 GSL

1426 BRU16042032P Sedilix-DM Linctus Dextromethorphan (as Hydrobromide) 15mg/5mL; Pseudoephedrine (as Hydrochloride) 30mg/5mL; Promethazine (as Hydrochloride) 3.125mg/5mL

Xepa-Soul Pattinson (M) Sdn Bhd, Malaysia.

Hongkiat Trading & Company 21 Jun 2021 till 20 Jun 2026 POM

1427 BRU16042033P Aloxi Solution for Injection 50mcg/ml

Palonosetron Hydrochloride 56 mcg eqv to Palonosetron 50 mcg (0.050 mg)

Pierre-Fabre Medicament Production, France.

Zuellig Pharma (B) Sdn Bhd 21 Jun 2016 till 20 Jun 2021 POM

1428 BRU16042034P Taver Tablet 200mg Carbamazepine 200mg Medochemie Ltd., (Factory AZ), Limassol, Cyprus

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

1429 BRU16042035NP Axcel B Complex Tablet Vitamin B1 10mg; Vitamin B2 3mg; Vitamin B6 1mg; Cyanocobalamine 5mcg; Calcium Pantothenate 1mg; Nicotinamide 25mg

Kotra Pharma (M) Sdn Bhd, Malaysia.

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 GSL

1430 BRU16042036P Pharmaniaga Allopurinol Tablet 300mg

Allopurinol 300mg Pharmaniaga Manufacturing Berhad, Malaysia.

G & H Trading Company 21 Jun 2021 till 20 Jun 2026 POM

1431 BRU16042037NP Povidin Solution 10% Povidone-Iodine 10% w/v (equivalent to 1% of Available Iodine)

Xepa-soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 21 Jun 2021 till 20 Jun 2026 GSL

1432 BRU16052038P GPO-L-OneTM 500mg Tablet Deferiprone 500mg The Government Pharmaceutical Organization (GPO), Thailand

K-Seri Pharma Sdn Bhd 21 Jun 2021 till 20 Jun 2026 POM

BDMCA/RMP/1220 Page 100 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1433 BRU16052039NP Noxworm Chewtab Albendazole 200mg Winwa Medical Sdn. Bhd., Malaysia

Yuh Hua Trading Company 21 Jun 2016 till 20 Jun 2021 GSL

1434 BRU16052041P Zoratadine Syrup 5mg/5ml Loratadine 5mg/5ml HOE Pharmaceuticals Sdn. Bhd., Malaysia

G&H Trading Company 21 Jun 2016 till 20 Jun 2021 P

1435 BRU16052042P Axcel Oxymetazoline 0.025% Nasal Drop

Oxymetazoline hydrochloride 0.025% w/v

Kotra Pharma (M) Sdn. Bhd., Malaysia

Medicorp Sdn Bhd 21 Jun 2021 till 20 Jun 2026 P

1436 BRU16052044P; BRU16052044PS2

Zometa Solution for Infusion 4mg/100ml

Zoledronic Acid (anhydrous) 4mg/100ml corresponding to 4.264mg Zoledronic Acid Monohydrate

Novartis Pharma Stein AG, Switzerland; Fresenius Kabi Austria GmbH, Austria (S2)

G & H Trading Company 21 Jun 2021 till 20 Jun 2026 POM

1437 BRU16052045P Novomin Tablet 50mg Dimenhydrinate 50mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia.

Hongkiat Trading & Company 22 Jun 2021 till 20 Jun 2026 POM

1438 BRU16062046P Valzaar 80mg Tablets Valsartan 80mg Torrent Pharmaceuticals Ltd, India

K-Seri Pharma Sdn. Bhd 08 November 2021 till 07 November 2026

POM

1439 BRU16062047P Valzaar 160mg Tablets Valsartan 160mg Torrent Pharmaceuticals Ltd, India

K-Seri Pharma Sdn. Bhd 08 November 2021 till 07 November 2026

POM

1440 BRU16062048P Tozaar 50mg tablet Losartan potassium 50mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 08 November 2016 till 07 November 2021

POM

1441 BRU16062049P; BRU16062049PS2

Seebri Breezhaler 50mcg Inhalation Powder Hard Capsules

Glycopyrronium bromide 63mcg (corresponding to 50 mcg Glycopyrronium)

Novartis Pharma Stein AG., Switzerland; Novartis Farmaceutica SA, Spain (S2)

Zuellig Pharma (B) Sdn Bhd 08 November 2021 till 07 November 2026

POM

1442 BRU16062052P Tidact Injection 150mg/ml Clindamycin (as phosphate) 150mg/ml Yung Shin Pharmaceutical Ind. Co. Ltd., Republic of China

Asterix United (B) Sdn Bhd 08 November 2016 till 07 November 2021

POM

1443 BRU16062053P APO-Risperidone Tablets 1mg Risperidone 1mg Apotex Inc, Canada Medicorp Sdn Bhd 08 November 2021 till 07 November 2026

POM

1444 BRU16062054P Betmiga Prolonged-Release Tablets 25mg

Mirabegron 25mg Avara Pharma Technologies, Inc., USA

Medipharm Sdn Bhd 08 November 2016 till 07 November 2021

POM

1445 BRU16062055P Betmiga Prolonged-Release Tablets 50mg

Mirabegron 50mg Avara Pharma Technologies, Inc., USA

Medipharm Sdn Bhd 08 November 2016 till 07 November 2021

POM

1446 BRU16062056P Axcel Mometasone 0.1% Cream

Mometasone furoate (micronised) 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 08 November 2021 till 07 November 2026

POM

1447 BRU16072057P Dipeptiven Infusion 200mg/ml N(2)-L-Alanyl-L-glutamine 200mg/ml Frensius Kabi Austria GmbH, Austria

Zuellig Pharma (B) Sdn Bhd 08 November 2021 till 07 November 2026

POM

1448 BRU16072058P Noxafil 100mg tablet Posaconazole 100mg N.V Organon, Netherlan Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07 November 2021

POM

1449 BRU16072059P Onegaba 300mg capsules Gabapentin 300mg Aurobindo Pharma Limited (Unit III), India

K-Seri Pharma Sdn Bhd 08 November 2021 till 07 November 2026

POM

1450 BRU16072060P Pethidine-Hameln Solution for Injection 50mg/ml

Pethidine Hydrochloride 50mg/ml

Siegfried Hameln GmbH, Germany

Medicorp Sdn Bhd 08 November 2016 till 07 November 2021

POM

1451 BRU16072061P Axcel Clobetasol 0.05 Ointment

Clobetasol Propionate (micronized) 0.05% w/w

Kotra Pharma (M) Sdn Bhd.,Malaysia.

Medicorp Sdn Bhd 08 November 2021 till 07 November 2026

POM

BDMCA/RMP/1220 Page 101 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1452 BRU16072062P Prednisolone syrup 5mg/5ml Each 5ml contains: Prednisolone (as salt of prednisolone) 5mg

Beacons Pharmaceutical Pte Ltd, Singapore

Hong Kiat Trading & Co 08 November 2016 till 07 November 2021

POM

1453 BRU16082063NP Zenalb 4.5%, Human Albumin Solution 4.5%

Human Albumin Solution 4.5% Bio Products Laboratory Limited, UK

MediPharm Sdn Bhd 08 November 2016 till 07 November 2021

POM

1454 BRU16082064P Axcel Lamivudine 100mg Tablet

Lamivudine 100mg Kotra Pharma (M) Sdn. Bhd., Malaysia

Medicorp Sdn Bhd 08 November 2016 till 07 November 2021

POM

1455 BRU16082065P Calpo Suspension Mebendazole 100mg/5ml Winwa Medical Sdn. Bhd., Malaysia

Yuh Hua Trading Company 08 November 2016 till 07 November 2021

GSL

1456 BRU16082066NP Alphanate® 250IU Factor VII 250IU and von Willebrand Factor >400IU/1000IU Factor VII

Grifols Biologicals LLC, USA Hongkiat Trading & Company 08 November 2016 till 07 November 2021

POM

1457 BRU16082067P Anoro Ellipta 62.5/25 micrograms inhalation powder, pre-dispensed

Each pre-dispensed dose contains 62.5 micrograms umeclidinium (equivalent to 74.2 micrograms of umeclidinium bromide) and 25 micrograms vilanterol (as trifenatate)

GlaxoSmithKline LLC, North Carolina United States

Zuellig Pharma (B) Sdn Bhd 08 November 2021 till 07 November 2026

POM

1458 BRU16082068NP RINS® NS Sodium Chloride 0.9% w/v Irrigation Solution BP

Sodium Chloride 0.9% w/v Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 08 November 2016 till 07 November 2021

GSL

1459 BRU16092069P Sifrol Extended Release 0.375mg tablet

Pramipexole Dihydrochloride Monohydrate 0.375mg (eqv. to 0.26mg pramipexole free base)

Boehringer Ingelheim Pharma gmbH & Co. KG, Germany

Hongkiat Trading & Company 08 November 2016 till 07 November 2021

POM

1460 BRU16092070P Sifrol Extended Release 1.5mg tablet

Pramipexole Dihydrochloride Monohydrate 1.5mg (eqv. to 1.05mg pramipexole free base)

Boehringer Ingelheim Pharma gmbH & Co. KG, Germany

Hongkiat Trading & Company 08 November 2016 till 07 November 2021

POM

1461 BRU16092071NP Mentholatum Deep Heating Rub Extra Strength Cream

Methyl Salicylate 30%; Menthol 8%

The Mentholatum Co., USA. Hamitan Marketng, Brunei Darussalam

08 November 2016 till 07 November 2021

GSL

1462 BRU16092072P GlobalVacc Al-Shifa HIB Each dose of 0.5ml contains: Purified Capsular Polysaccharide Hib (PRP) –10mcg (Hib Polysaccharide) (PRP) Tetanus Toxoid (carrier protein) –19 to 33mcg

Serum Institute India Ltd., India Bruvac Pharma Sdn Bhd 08 November 2016 till 07 November 2021

POM

BDMCA/RMP/1220 Page 102 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1463 BRU16092073P Adrenaline (Epinephrine) Injection 1:1000

Adrenaline (Epinephrine) as acid tartrate

Mc Carthys Laboratories Ltd., UK Medicorp Sdn Bhd 08 November 2016 till 07 November 2021

POM

1464 BRU16092074P Axcel Mometasone 0.1% Ointment Mometasone Furoate

(micronised) 0.1% w/w

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 08 November 2021 till 07 November 2026

POM

1465 BRU16092075P Amphotret for Injection U.S.P. 50mg

Amphotericin B U.S.P. 50mg Bharat Serums And Vaccines Ltd, India

K-Seri Pharma Sdn Bhd 08 November 2021 till 07 November 2026

POM

1466 BRU16092076NP Alumag Plus Tablet Per tablet: Aluminium Hydroxide Dried Gel 250mg; Magnesium Trisilicate Light 250mg; Simethicone 30mg

Beacons Pharmaceuticals Pte Ltd, Singapore

HongKiat Trading Co 08 November 2016 till 07 November 2021

GSL

1467 BRU16102079PT Baxter Chlorhexidine Acetate 0.1% w/v Antiseptic Solution

Chlorhexidine (as Acetate)

Baxter Healthcare Pty Ltd, Australia

Zuellig Pharma (B) Sdn Bhd 08 November 2019 till 26 Jan 2024

GSL

1468 BRU16102080P Magurol 2mg tablet Doxazosin mesilate eq. to doxazosin base 2mg

Medochemie Ltd Central Factory, Cyprus

Medicorp Sdn. Bhd 08 November 2016 till 07 November 2021

POM

1469 BRU16102081P Magurol 4mg tablet Doxazosin mesilate eq. to doxazosin base 4mg

Medochemie Ltd Central Factory, Cyprus

Medicorp Sdn. Bhd 08 November 2016 till 07 November 2021

POM

1470 BRU16102083P Xolair 75mg powder for solution for injection

Omalizumab 75mg. Reconstituted Xolair contains 125mg/ml of omalizumab (75mg in 0.6ml)

Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 08 November 2021 till 07 November 2026

POM

1471 BRU16102084P Bilaxten 20mg tablet Bilastine 20mg A.Menarini Manufacturing Logistic and Services S.r.l., Italy

Zuellig Pharma (B) Sdn Bhd 08 November 2016 till 07 November 2021

POM

1472 BRU16102085P Loxin Injection (5ml amp) (Dopamine HCl)

Dopamine hydrochloride Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 08 November 2016 till 07 November 2021

POM

1473 BRU16102086P Mycamine 50mg/vial Powder for Solution for Infusion

Micafungin (as sodium) 50mg/via

Astellas Pharma Tech Co., Ltd., Japan

MediPharm Sdn Bhd 08 November 2021 till 07 November 2026

POM

1474 BRU16102087P Vaxcel Fluconazole 2mg/ml IV Infusion

Fluconazole 2mg/ml Kotra Pharma (M) Sdn. Bhd.,Malaysia

Medicorp Sdn Bhd 08 November 2016 till 07 November 2021

POM

1475 BRU16102088P Sellon Shampoo Selenium sulfide 2.5% w/v Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 08 November 2021 till 07 November 2026

P

BDMCA/RMP/1220 Page 103 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1476 BRU16102089NP Daily-vite multivitamin syrup for children

Each 5mL contains: Vitamin A: 2,000 IU Vitamin D :400 IU Vitamin B1: 1.2 mg Vitamin B2: 1.3 mg Vitamin B6: 0.8 mg Vitamin B12 (cyanocobalamin): 3.0 mcg Niacinamide: 10mg Vitamin C (Ascorbic Acid): 50 mg L-Lysine Monohydrochloride: 37.5 mg

Dynapharm (M) Sdn Bhd, Malaysia

Medicorp Sdn. Bhd 08 November 2021 till 07 November 2026

GSL

1477 BRU16102090NP Ubat Batuk Cap Kaki Tiga (Solution)

Guaifenesin 100mg/5ml Syarikat Wen Ken Drug Sdn Bhd, , Malaysia

Syarikat Rajamas Bersama 08 November 2016 till 07 November 2021

GSL

1478 BRU16102091P Vaxcel Lignocaine 1% Injection Lignocaine Hydrochloride 1% (50mg/5ml)

Kotra Pharma (M) Sdn. Bhd.,Malaysia

Medicorp Sdn. Bhd 08 November 2021 till 07 November 2026

POM

1479 BRU16112092P Risperidone Orally Disintegrating Tablet 3mg

Risperidone 3.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd 21 March 2017 till 20 March 2022

POM

1480 BRU16112093P Risperidone Orally Disintegrating Tablet 2mg

Risperidone 2.0mg Jubilant Generics Ltd, India Asterix United (B) Sdn Bhd 21 March 2017 till 20 March 2022

POM

1481 BRU16112094P Goutnor 0.5mg tablet Colchicine 0.5mg Noripharma Sdn. Bhd., Malaysia K-Seri Pharma Sdn. Bhd. 21 March 2017 till 20 March 2022

POM

1482 BRU16112095P Salbutamol Syrup 2mg/5ml Salbutamol sulphate 2mg/5ml Y.S.P. Industries (M) Sdn. Bhd., Malaysia

Asterix United (B) Sdn Bhd. 21 March 2017 till 20 March 2022

POM

1483 BRU16112097NP Noflux Tablet 90mg Lysozyme chloride 90mg Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd. 21 March 2017 till 20 March 2022

GSL

1484 BRU16112098NP Calamine Lotion with Menthol Calamine powder 15% w/v, zinc oxide 5% w/v and menthol 0.4% w/v

Beacons Pharmaceuticals Pte Ltd., Singapore

Hongkiat Trading & Company 21 March 2017 till 20 March 2022

GSL

1485 BRU16112099P Toujeo 300 units/ml Solution For Injection In Pre-Filled Pen

Insulin glargine 300units/ml (10.91mg/ml)

Sanofi-Aventis Deutschland GmbH, Germany

MediPharm Sdn Bhd. 21 March 2017 till 20 March 2022

POM

1486 BRU16112100P Apo-Levocarb Tablet 100mg/25mg

Levodopa 100mg; Carbidopa 25mg Apotex Inc., Canada Medicorp Sdn Bhd, 21 March 2017 till 20 March 2022

POM

1487 BRU16112102NP White Balsem, Three Legs Brand

Methyl salicylate 18% w/w, Menthol 9% w/w and Camphor 5% w/w

Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 21 March 2017 till 20 March 2022

GSL

1488 BRU16112103NP Tinea Skin Solution, Three Legs Brand

Salicylic acid 5% w/v and Benzoic acid 2% w/v

Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 21 March 2017 till 20 March 2022

GSL

1489 BRU16112104NP Three Legs Yellow Lotion Acriflavine 0.1%w/v Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 21 March 2017 till 20 March 2022

GSL

1490 BRU16112105P Furosemide-hameln 10mg/ml Injection

Furosemide 10mg/ml Siegfried Hameln GmbH, Germany

Medicorp Sdn Bhd 21 March 2017 till 20 March 2022

POM

BDMCA/RMP/1220 Page 104 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1491 BRU16112106NP Tolnaftate Cream Three Legs Brand

Tolnaftate 1% w/v Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 21 March 2017 till 20 March 2022

GSL

1492 BRU16112107NP Ubat Serbuk Cap Kaki Tiga 600mg/sachet

Acetylsalicylic acid (Aspirin) 600mg / sachet

Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 21 March 2017 till 20 March 2022

GSL

1493 BRU16112108P Denkan (1) Injection i) Lignocaine HCl monohydrate eq. to Lignocaine HCl Anhydrous 20mg (2%w/v)

ii) Epinephrine Acid Tartrate eq. to Epinephrine 0.01mg (1:100 000)

Duopharma (M) Sdn Bhd., Malaysia.

K-Seri Pharma Sdn Bhd. 21 March 2017 till 20 March 2022

POM

1494 BRU16112109NP 5% Dextrose in 0.9% Sodium Chloride Solution for Intravenous Infusion

Each 100ml contains: Dextrose monohydrate 5.00g and Sodium Chloride 900mg

Euro-Med Laboratories Phil., Inc., Philippines

Medicorp Sdn Bhd 21 March 2017 till 20 March 2022

POM

1495 BRU16112110P Zylovaa Tablet 100mg Losartan potassium 100mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 21 March 2017 till 20 March 2022

POM

1496 BRU16122111P Ceflour Injection 0.75g Cefuroxime Sodium 0.75g Yung Shin Pharmaceutical Ind. Co. Ind., Republic of China

K-Seri Pharma Sdn. Bhd. 21 March 2017 till 20 March 2022

POM

1497 BRU16122112P Ziagen Tablets 300mg Abacavir 300mg (as abacavir sulphate) GlaxoSmithKline Pharmaceuticals S.A., Poland

Zuellig Pharma (B) Sdn Bhd 21 March 2017 till 20 March 2022

POM

1498 BRU16122113P Apo-Alendronate 70mg tablet Alendronate Sodium Trihydrate eq to Alendronic acid 70mg

Apotex Inc. Canada MediPharm Sdn Bhd 21 March 2017 till 20 March 2022

POM

1499 BRU16122114P Tensiber Film Coated Tablet 300mg

Irbesartan 300mg Lek Pharmaceuticals d.d., Slovenia

Zuellig Pharma (B) Sdn Bhd 21 March 2017 till 20 March 2022

POM

1500 BRU16122115P Cala-My Lotion Calamine 15% w/v, Zinc Oxide 5% w/v HOE Pharmaceuticals Sdn. Bhd., Malaysia

G & H Trading Company 21 March 2017 till 20 March 2022

GSL

1501 BRU16122116P Apo-Quetiapine 25mg Tablet Quetiapine Fumarate equivalent to 25mg Quetiapine

Apotex Inc, Canada MediPharm Sdn Bhd 21 March 2017 till 20 March 2022

POM

1502 BRU16122117P Apo-Quetiapine 100mg Tablet Quetiapine Fumarate equivalent to 100mg Quetiapine

Apotex Inc, Canada MediPharm Sdn Bhd 21 March 2017 till 20 March 2022

POM

1503 BRU16122118P Apo-Quetiapine 200mg Tablet Quetiapine Fumarate equivalent to 200mg Quetiapine

Apotex Inc, Canada MediPharm Sdn Bhd 21 March 2017 till 20 March 2022

POM

1504 BRU16122119NP Actimax 500 tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 21 March 2017 till 20 March 2022

P (10’s x 15, 10’s x 50 )

1505 BRU16122120NP Betadine® Dry Powder Spray 2.5%

Povidone –Iodine 2.5% Mundipharma Pharmaceuticals Limited, Cyprus

Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till 20 March 2022

GSL

1506 BRU16122121NP Flanil Analgesic Cream Methyl Salicylate 10.20% w/w, Menthol 5.44% w/w and Eugenol1.36% w/w

Biolab Company Ltd., Thailand Hongkiat Trading & Co. 21 March 2017 till 20 March 2022

GSL

1507 BRU16122122NP Betadine® Antiseptic Skin Cleanser 7.5% w/v

Povidone-Iodine 7.5% w/v PT Mahakam Beta Farma, Indonesia

Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till 20 March 2022

GSL

BDMCA/RMP/1220 Page 105 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1508 BRU16122123P Oxynorm Sterile Solution for Injection or Infusion 10mg/mL

Oxycodone hydrochloride 10mg/ml (equivalent to 9 mg/ml Oxycodone)

B.Braun Melsungen AG, Berlin, Germany

Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till 20 March 2022

POM

1509 BRU16122124P Ferriprox 500mg Tablet Deferiprone 500mg Apotex Inc., Canada Medicare 21 March 2017 till 20 March 2022

POM

1510 BRU16122125P Vaxcel Lignocaine 2% Injection Lignocaine Hydrochloride 2% (200mg/10ml)

Kotra Pharma (M) Sdn. Bhd.,Malaysia

Medicorp Sdn. Bhd 21 March 2017 till 20 March 2022

POM

1511 BRU16122126P Oxynorm Oral Solution 5mg/5mL

Each 5ml contains oxycodone base 4.5mg as oxycodone hydrochloride 5mg

Mundipharma Pharmaceuticals Limited, Cyprus

Zuellig Pharma (B) Sdn. Bhd. 21 March 2017 till 20 March 2022

POM

1512 BRU16122127P Shintamet Film Coated Tablet 200mg

Cimetidine 200mg Y.S.P. Industries (M) Sdn. Bhd., Malaysia

Asterix United (B) Sdn. Bhd. 21 March 2017 till 20 March 2022

POM

1513 BRU17012130PS2; BRU17012130PS3

Tarceva Tablet 100mg Erlotinib 100mg Delpharm Milano S.r.L., Segrate (MI) Italy (S2); F.Hoffman La Roche AG, Switzerland (S3)

Hongkiat Trading & Co 21 March 2017 till 20 March 2022

POM

1514 BRU17012131PS2; BRU17012131PS3

Tarceva Tablet 150mg Erlotinib 150mg Delpharm Milano S.r.L., Segrate (MI) Italy (S2); F.Hoffman La Roche AG, Switzerland (S3)

Hongkiat Trading & Co 21 March 2017 till 20 March 2022

POM

1515 BRU17012132P Apo-Gliclazide 30mr MR tablet

Gliclazide 30mg Apotex Inc. Canada Medicorp Sdn. Bhd 21 March 2017 till 20 March 2022

POM

1516 BRU17012134NP Orregel Choline salicylate 8.70% w/w; and Cetylpyridinium Chloride0.10% w/w

HOE Pharmaceuticals Sdn. Bhd., Malaysia

G & H Trading Company 21 March 2017 till 20 March 2022

GSL

1517 BRU17012135P Gaviscon peppermint tablets Sodium alginate 250mg Sodium bicarbonate 133.5mg Calcium carbonate 80mg

Reckitt Benckiser Healthcare (UK) Limited, Dansom Lane, East Yorkshire, Hull HU8 7DS, United Kingdom

Syarikat Aliaa Sdn Bhd 21 March 2017 till 20 March 2022

GSL

1518 BRU17012136NP Senokot tablet Sennoside B 7.5mg Reckitt Benckiser Healthcare (UK) Ltd., UK

Zuellig Pharma (B) Sdn Bhd 21 March 2017 till 20 March 2022

GSL

1519 BRU17012137P Tussidex Forte Linctus Dextromethorphan hydrobromide 15mg/5ml

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hong Kiat Trading Co

21 March 2017 till 20 March 2022

POM

1520 BRU17012138P Floctil 250mg Capsule Azithromycin dihydrate eq. to Azithromycin 250mg

Unison Laboratories Co. Ltd, Thailand

Hong Kiat Trading Co 21 March 2017 till 20 March 2022

POM

1521 BRU17012139P Selegos 5mg Tablet Selegiline Hydrochloride 5mg

Medochemie Ltd., Cyprus Hong Kiat Trading Co

21 March 2017 till 20 March 2022

POM

1522 BRU17012140P Timolol-POS 0.5% Eye Drop Timolol maleate 6.84mg/ml Ursapharm Arzneimittel GmbH, Germany

Medicorp Sdn. Bhd 21 March 2017 till 20 March 2022

POM

1523 BRU17012141P Metformin Tablet 500mg Metformin Hydrochloride 500mg Dynapharm (M) Sdn Bhd., Malaysia

Medicorp Sdn. Bhd 21 March 2017 till 20 March 2022

POM

BDMCA/RMP/1220 Page 106 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1524 BRU17012142P Axcel Cinnarizine Tablet Cinnarizine 25mg Kotra Pharma (M) Sdn. Bhd.,Malaysia

Medicorp Sdn. Bhd 21 March 2017 till 20 March 2022

POM

1525 BRU17012143NP UO Cream 100mg/g (10%) Carbonyldiamide (Urea) 100mg/g (10%)

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd,

21 March 2017 till 20 March 2022

GSL

1526 BRU17012144NP Axcel Vitalic Tablet Vitamin B1 (Thiamine) 100mg Vitamin B6 (Pyridoxine) 200mg Vitamin B12 (Cyanocobalamine) 200mcg

Kotra Pharma (M) Sdn. Bhd.,Malaysia

Medicorp Sdn. Bhd 21 March 2017 till 20 March 2022

P

1527 BRU17012145P Iqnyde Tablet 50mg Sildenafil Citrate 70.25mg equivalent to Sildenafil 50mg

Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 21 March 2017 till 20 March 2022

POM

1528 BRU17022146P Azarga Eye Drops Suspension Brinzolamide 10mg/mlTimolol maleate 5mg/ml

S.A. Alcon, Couvreur N.V., Belgium

Medipharm Sdn Bhd 21 March 2017 till 20 March 2022

POM

1529 BRU17022147P Pharmaniaga Dermasole Cream 0.1% w/w

Betamethasone 17-valerate 0.1% w/w Pharmaniaga Manufacturing Berhad, Malaysia

G&H Trading Co 21 March 2017 till 20 March 2022

POM

1530 BRU17022148P Jardiance 10mg Film-coated Tablet

Empagliflozin 10mg Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 21 March 2017 till 20 March 2022

POM

1531 BRU17022149P Jardiance 25mg Film-coated Tablet

Empagliflozin 25mg Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 21 March 2017 till 20 March 2022

POM

1532 BRU17022152P Glumet DC Tablet 500mg Metformin hydrochloride 500mg Pharmaniaga Manufacturing Berhad, Malaysia

G&H Trading Co 21 March 2017 till 20 March 2022

POM

1533 BRU17022153P Targin Prolonged Release Tablets 5mg/2.5mg

Each tablet contains:4.5mg of oxycodone as 5mg oxycodone hydrochloride2.25mg of naloxone as 2.5mg naloxone hydrochloride.

Bard Pharmaceuticals Limited, UK

Zuellig Pharma (B) Sdn Bhd 21 March 2017 till 20 March 2022

POM

1534 BRU17022154P Targin Prolonged Release Tablets 10mg/5mg

Each tablet contains:9mg of oxycodone as 10mg oxycodone hydrochloride4.5mg of naloxone as 5mg naloxone hydrochloride.

Bard Pharmaceuticals Limited, UK

Zuellig Pharma (B) Sdn Bhd 21 March 2017 till 20 March 2022

POM

1535 BRU17022155P Targin Prolonged Release Tablets 20mg/10mg

Each tablet contains:18mg of oxycodone as 20mg oxycodone hydrochloride9mg of naloxone as 10mg naloxone hydrochloride.

Bard Pharmaceuticals Limited, UK

Zuellig Pharma (B) Sdn Bhd 21 March 2017 till 20 March 2022

POM

1536 BRU17022156P Targin Prolonged Release Tablets 40mg/20mg

Each tablet contains:36mg of oxycodone as 40mg oxycodone hydrochloride18mg of naloxone as 20mg naloxone hydrochloride.

Bard Pharmaceuticals Limited, UK

Zuellig Pharma (B) Sdn Bhd 21 March 2017 till 20 March 2022

POM

BDMCA/RMP/1220 Page 107 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1537 BRU17022157P Pristine Shampoo 2% w/w Ketoconazole 2% w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd

Hongkiat Trading & Company 21 March 2017 till 20 March 2022

GSL

1538 BRU17022158NP Effervescent Mouthwash Tablets

Thymol EP 0.77mg; Menthol EP 1.87mg

JL Bragg Ltd, UK Hongkiat Trading & Company 21 March 2017 till 20 March 2022

GSL

1539 BRU17022159P Salmol Expectorant Each 5ml contains: Salbutamol Sulfate equivalent to Salbutamol 1.0 mg; Guaiphenesin 50.0 mg

Biolab Co., Ltd, Thailand Hongkiat Trading & Company 21 March 2017 till 20 March 2022

POM

1540 BRU17022160P Acnotin 10 Capsule Isotretinoin 10mg Mega Lifesceinces Public Company Limited, Thailand

G&H Trading Co 21 March 2017 till 20 March 2022

POM

1541 BRU17022161P Acnotin 20 Capsule Isotretinoin 20mg Mega Lifesceinces Public Company Limited, Thailand

G&H Trading Co 21 March 2017 till 20 March 2022

POM

1542 BRU17022162P Ketobid Shampoo Ketoconazole 2% w/v SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Co 21 March 2017 till 20 March 2022

GSL

1543 BRU17022163P Axcel Glucosamine-500 Tablet Crystalline Glucosamine Sulphate Potassium Chloride 665mg equivalent to Glucosamine Sulphate 500mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 21 March 2017 till 20 March 2022

GSL

1544 BRU17022164P Cef-4 1G Injection Ceftazidime (as pentahydrate) 1g Siam Bheasach Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 21 March 2017 till 20 March 2022

POM

1545 BRU17032165P Asthator 4mg Chewable Tablet

Montelukast sodium 4.160mg eq. to montelukast 4mg

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022

POM

1546 BRU17032166P Asthator 5mg Chewable Tablet

Montelukast sodium 5.20mg eq. to montelukast 5mg

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022

POM

1547 BRU17032167P Asthator 10mgTablet Montelukast sodium 10.40mg eq. to montelukast 10mg

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022

POM

1548 BRU17032168NP OLICLINOMEL N7-1000E EMULSION FOR INFUSION

1000ml of the mixture contain: 20% Lipid emulsion compartment (corresponding to 20g/100ml) (200ml); 40% Glucose solution compartment (corresponding to 40g/100ml) (400ml); 10% Amino acid solution compartment (corresponding to 10g/100ml) (400ml) (For Detailed Formulation referred to Dossier)

Baxter S.A., Belgium Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

1549 BRU17032169P PHARMANIAGA ZICONAL CREAM 2% W/W

Ketoconazole 2.0% w/w Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Co 11 July 2017 till 10 July 2022

GSL

BDMCA/RMP/1220 Page 108 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1550 BRU17032170P Zolennic Concentrate for Solution for IV Infusion

Each vial (5ml) contains Zoledronic acid monohydrate equivalent to Zoledronic acid anhydrous 4mg

Siam Bheasach Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 11 July 2017 till 10 July 2022

POM

1551 BRU17032171P Dynadryl Syrup Each 5ml contains: Diphenhydramine Hydrochloride 14mg; Sodium Citrate 57mg; Ammonium Chloride 135mg

Dynapharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022

POM

1552 BRU17032172P Depo Geston Injection 50mg/ml

Medroxyprogesterone Acetate 50mg/ml

PT. Triyasa Nagamas Farma, Indonesia

Hongkiat Trading & Company 11 July 2017 till 10 July 2022

POM

1553 BRU17032173P Axcel Valacyclovir-500 Tablet Valacyclovir Hydrochloride equivalent to Valacyclovir 500mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022

POM

1554 BRU17032174P Pharmaniaga Lidocaine Hydrochloride 2% w/v Injection

Lidocaine Hydrochloride 2% w/v (200mg/10mL)

Pharmaniaga LifeScience Sdn. Bhd.,

G & H Trading Co 11 July 2017 till 10 July 2022

POM

1555 BRU17032175NP Axcel Paracetamol-250 Suspension (Strawberry)

Paracetamol 250mg/5mL Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022

GSL

1556 BRU17042176NP OLICLINOMEL N4-550E EMULSION FOR INFUSION

1000ml of the mixture contain: 20% Lipid emulsion compartment (corresponding to 20g/100ml) (200ml); 40% Glucose solution compartment (corresponding to 40g/100ml) (400ml); 10% Amino acid solution compartment (corresponding to 10g/100ml) (400ml) (For Detailed Formulation referred to Dossier)

Baxter S.A., Belgium Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

1557 BRU17042177NP HUACHI ENEMA Each 20ml enema contains:Glycerin 30% w/v 6g; Sodium Chloride 15% w/v 3g

Jen Sheng Pharmaceutical Co. Ltd., Taiwan

Yuh Hua Trading Company 11 July 2017 till 10 July 2022

GSL

1558 BRU17042178P Anexate Injection 0.5mg/5ml Flumazenil 0.5mg Cenexi SAS, France Medicare 11 July 2017 till 10 July 2022

POM

1559 BRU17042179P Glumet XR Tablet 500mg Metformin Hydrochloride DC Granules 577.36mg (equivalent to Metformin Hydrochloride 500mg)

Pharmaniaga manufacturing Berhad, Malaysia

G & H Trading Co 11 July 2017 till 10 July 2022

POM

1560 BRU17042180NP POVIL ANTACID MIXTURE Each 10ml contains:Dried Aluminium Hydroxide …400mg Magnesium Hydroxide………..400mg

Winwa Medical Sdn Bhd, Pulau Pinang, Malaysia

Yuh Hua Trading Company 11 July 2017 till 10 July 2022

GSL

1561 BRU17042181P Zimmex 20 Tablet Simvastatin 20mg Silom Medical Co Ltd, Thailand Medicorp Sdn Bhd 11 July 2017 till 10 July 2022

POM

BDMCA/RMP/1220 Page 109 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1562 BRU17042182P KOP 2.5% Gel (Ketoprofen BP) Ketoprofen 2.5% w/w Square Pharmaceuticals Ltd., Bangladesh

Hongkiat Trading & Company 11 July 2017 till 10 July 2022

P

1563 BRU17042183P Dextracin Eye/Ear Drops 1. Dexamethasone Sodium Phosphate eq. to Dexamethasone Phosphate 0.1% w/v2. Neomycin Sulphate 0.5% w/v

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 11 July 2017 till 10 July 2022

POM

1564 BRU17042184P TRIPLIXAM 2.5MG/0.625MG/5MG FILM-COATED TABLETS

Perindopril arginine 2.5mg (corresponding to 1.6975mg of perindopril)Indapamide 0.625mgAmlodipine besilate 6.935mg (corresponding to 5mg of amlodipine)

Servier (Ireland) Industries Ltd, Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

1565 BRU17042185P TRIPLIXAM 5MG/1.25MG/5MG FILM-COATED TABLETS

Perindopril arginine 5mg (corresponding to 3.395mg of perindopril)Indapamide 1.25mgAmlodipine besilate 6.935mg (corresponding to 5mg of amlodipine)

Servier (Ireland) Industries Ltd, Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

1566 BRU17042186P TRIPLIXAM 5MG/1.25MG/10MG FILM-COATED TABLETS

Perindopril arginine 5mg (corresponding to 3.395mg of perindopril)Indapamide 1.25mgAmlodipine besilate 13.870mg (corresponding to 10mg of amlodipine)

Servier (Ireland) Industries Ltd, Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

1567 BRU17042187P TRIPLIXAM 10MG/2.5MG/5MG FILM-COATED TABLETS

Perindopril arginine 10mg (corresponding to 6.79mg of perindopril)Indapamide 2.5mgAmlodipine besilate 6.935mg (corresponding to 5mg of amlodipine)

Servier (Ireland) Industries Ltd, Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

1568 BRU17042188P TRIPLIXAM 10MG/2.5MG/10MG FILM-COATED TABLETS

Perindopril arginine 10mg (corresponding to 6.79mg of perindopril)Indapamide 2.5mgAmlodipine besilate 13.870mg (corresponding to 10mg of amlodipine)

Servier (Ireland) Industries Ltd, Ireland

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

BDMCA/RMP/1220 Page 110 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1569 BRU17042189P Cotren Vaginal Tablet 500mg Clotrimazole 500mg Biolab Company Ltd., Thailand Hongkiat Trading & Company 11 July 2017 till 10 July 2022

P

1570 BRU17042190P Axcel Bromhexine Tablet Bromhexine Hydrochloride 8mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022

P

1571 BRU17042191P Ameket Injection 2mL Ranitidine Hydrochloride eq. to Ranitidine 25mg/ml

SM Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Co 11 July 2017 till 10 July 2022

POM

1572 BRU17042192P Zocol 150mg Capsule Fluconazole 150mg SM Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Co 11 July 2017 till 10 July 2022

POM

1573 BRU17042193NP Anucare Ointment Each g contains Zinc Oxide 107.5mg (10.75% w/w); Peru Balsam 18.8mg (1.88% w/w); Benzyl Benzoate 12.5mg (1.25% w/w)

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 11 July 2017 till 10 July 2022

GSL

1574 BRU17052195P Pamorelin 3.75mg Powder for Suspension for Injection

Triptorelin (peptide base) 3.75mg equivalent to triptorelin embonate

Debiopharm Research and Manufacturing SA, Switzerland

Hongkiat Trading & Company 11 July 2017 till 10 July 2022

POM

1575 BRU17052196P Pamorelin 11.25mg Powder for Suspension for Injection

Triptorelin (peptide base) 11.25mg equivalent to triptorelin embonate

Debiopharm Research and Manufacturing SA, Switzerland

Hongkiat Trading & Company 11 July 2017 till 10 July 2022

POM

1576 BRU17052197P Pamorelin 22.5mg Powder for Suspension for Injection

Triptorelin (peptide base) 22.5mg equivalent to triptorelin embonate

Debiopharm Research and Manufacturing SA, Switzerland

Hongkiat Trading & Company 11 July 2017 till 10 July 2022

POM

1577 BRU17052198NP Weng Heng Tablet Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 11 July 2017 till 10 July 2022

P

1578 BRU17052199P MST CONTINUS 10MG PROLONGED RELEASE TABLETS

10mgMorphine sulphate Ph.Eur

Bard Pharmaceuticals Limited, UK

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

1579 BRU17052200P MST CONTINUS 30MG PROLONGED RELEASE TABLETS

Morphine sulphate 30mg Bard Pharmaceuticals Limited, UK

Zuellig Pharma (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

1580 BRU17052203P Maxiclear Sinus & Pain Relief Tablet 500mg/5mg

Paracetamol 500mg and phenylephrine hydrochloride 5mg

Sigma Laboratories Ltd, India Medipharm Sdn Bhd 11 July 2017 till 10 July 2022

P

1581 BRU17052204P Oxair Chewable Tablet 5mg Montelukast sodium 5.2mg (eq. to Montelukast 5mg)

Y.S.P Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 11 July 2017 till 10 July 2022

POM

1582 BRU17052205P Anacaine Injection 1% Lidocaine Hydrochloride 1%

SM Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 11 July 2017 till 10 July 2022

POM

1583 BRU17052206P Anacaine Injection 2% Lidocaine Hydrochloride 2%

SM Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 11 July 2017 till 10 July 2022

POM

1584 BRU17052207NP Ferromed Tablet 200mg Ferrous Fumarate BP 200mg SM Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 11 July 2017 till 10 July 2022

GSL

BDMCA/RMP/1220 Page 111 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1585 BRU17052208NP Calazite Lotion Calamine 15%w/v; Zinc oxide 5%w/v Winwa Medical Sdn Bhd, Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022

GSL

1586 BRU17052209P Acipan Injection 1mg/ml (1ml ampoule)

Atropine Sulphate 1mg/ml

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma 11 July 2017 till 10 July 2022

POM

1587 BRU17062210NP OLICLINOMEL N7-1000 EMULSION FOR INFUSION

1000ml of the mixture contain: 20% Lipid emulsion compartment (corresponding to 20g/100ml) (200ml); 40% Glucose solution compartment (corresponding to 40g/100ml) (400ml); 10% Amino acid solution compartment (corresponding to 10g/100ml) (400ml) (For Detailed Formulation referred to Dossier)

Baxter S.A., Belgium Zuellig Pharma (B) Sdn Bhd Sdn Bhd

11 July 2017 till 10 July 2022

POM

1588 BRU17062211P HYOSCINE BUTYLBROMIDE TABLET

Hyoscine N-butylbromide 10mg Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 11 July 2017 till 10 July 2022

POM

1589 BRU17062212NP SMOFKABIVEN Emulsion for Infusion

1000 ml of the mixture contain: 10% Amino acid solution with electrolytes compartment (corresponding to 10g/100ml) (508ml); 42% Glucose compartment (corresponding to 42g/100ml) (302ml); Lipid emulsion compartment (190ml);(For Detailed Formulation referred to Dossier)

Fresenius Kabi AB, Sweden Zuellig Pharma (B) Sdn Bhd Sdn Bhd

11 July 2017 till 10 July 2022

POM

1590 BRU17062213P Cosentyx 150mg Powder for Solution for Injection

Secukinumab 150mg Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd Sdn Bhd

11 July 2017 till 10 July 2022

POM

1591 BRU17062214P Cosentyx 150mg Solution for Injection in Pre-filled Syringe

Secukinumab 150mg Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd Sdn Bhd

11 July 2017 till 10 July 2022

POM

1592 BRU17062215P Cosentyx 150mg Solution for Injection in Pre-filled Pen

Secukinumab 150mg Novartis Pharma Stein AG, Switzerland; Sandoz GmbH – Schaftenau, Austria

Zuellig Pharma (B) Sdn Bhd Sdn Bhd

11 July 2017 till 10 July 2022

POM

1593 BRU17062216P Morphine-Hameln 10mg/ml Injection, 1mL

Morphine Sulphate 10mg/ml Siegfried Hameln GmbH, Germany

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022

POM

1594 BRU17062217P XTANDI SOFT CAPSULES 40MG

Enzalutamide 40mg Catalent Pharma Solutions LLC, USA

MediPharm Sdn Bhd 11 July 2017 till 10 July 2022

POM

1595 BRU17062218P PRAXBIND Solution for Injection/Infusion 50mg/ml

Idarucizumab 50mg/ml Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 11 July 2017 till 10 July 2022

POM

1596 BRU17062219NP Zam-Buk Ointment Each 100g contains: Eucalyptus oil 5.02g; Camphor 1.76g

Interthai Pharmaceutical Manufacturing Ltd, Thailand.

Zuellig Pharma (B) Sdn Bhd Sdn Bhd

11 July 2017 till 10 July 2022

GSL

BDMCA/RMP/1220 Page 112 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1597 BRU17062220P Axcel Sildenafil-100mg Tablet Sildenafil Citrate equivalent to Sildenafil 100mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 11 July 2017 till 10 July 2022

POM

1598 BRU17062221NP Hialid 0.3% Ophthalmic Solution

Purified Sodium Hyaluronate 0.3% Santen Pharmaceutical Co., Ltd., Japan

MediPharm Sdn Bhd 11 July 2017 till 10 July 2022

POM

1599 BRU17062222NP Hialid 0.1% Ophthalmic Solution

Purified Sodium Hyaluronate 0.1% Santen Pharmaceutical Co., Ltd., Japan

MediPharm Sdn Bhd 11 July 2017 till 10 July 2022

GSL

1600 BRU17072223P Monoclox 500mg Powder for Solution for Injection or Infusion

Cloxacillin sodium equivalent to cloxacillin 500mg

Medochemie Ltd., Cyprus Medicorp Sdn Bhd 03 October 2017 till 02 October 2022

POM

1601 BRU17072224P Simvor Tablets 10mg Simvastatin 10mg Ranbaxy (Malaysia) Sdn Bhd., Malaysia

Medipharm Sdn Bhd 03 October 2017 till 02 October 2022

POM

1602 BRU17072225P Gluvecron MR 30mg Tablet Gliclazide 30mg China Chemical & Pharmaceutical Co. Ltd., Taiwan

Medicorp Sdn Bhd 03 October 2017 till 02 October 2022

POM

1603 BRU17072226NP Restors Oral Powder i)Sodium Chloride BP 520mgii)Potassium Chloride BP 300mgiii) Trisodium Citrate Dihydrate BP 580mgiv) Glucose Anhydrous BP 2700mg

Winwa medical Sdn Bhd, Malaysia

Medicorp Sdn Bhd 03 October 2017 till 02 October 2022

GSL

1604 BRU17072227P Flumazenil-Hameln 0.1mg/ml injection

Flumazenil 0.1mg/ml Siegfried Hameln GmbH, Germany

Medicorp Sdn Bhd 03 October 2017 till 02 October 2022

POM

1605 BRU17082232P Xeljanz Film-Coated Tablet 5mg

Tofacitinib (as citrate) 5mg Pfizer Maufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02 October 2022

POM

1606 BRU17082233P Amoxicap 250 capsule Amoxicillin (as trihydrate 287mg) 250mg

Hovid Bhd., Malaysia G&H Trading Company 03 October 2017 till 02 October 2022

POM

1607 BRU17082234P Forxiga 5mg Film-Coated Tablet

Dapagliflozin 5mg AstraZeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02 October 2022

POM

1608 BRU17082235P Forxiga 10mg Film-Coated Tablet

Dapagliflozin 10mg AstraZeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02 October 2022

POM

1609 BRU17082236P Motigut Suspension 1ml/1ml Domperidone 1mg/ml Square Pharmaceuticals Ltd, Bangladesh

Hongkiat Trading Co 03 October 2017 till 02 October 2022

POM

1610 BRU17082237P Tanzaril Tablet 50mg Losartan Potassium 50mg Silom Medical Co. Ltd, Thailand Medicorp Sdn Bhd 03 October 2017 till 02 October 2022

POM

1611 BRU17082238P Maxiclear Sinus Relief Tablet 10mg

Phenylephrine hydrochloride 10mg Sigma Laboratories Ltd, India Medipharm Sdn Bhd 03 October 2017 till 02 October 2022

P

1612 BRU17082239P Shrizine Injection 25mg/ml Fluphenazine Decanoate BP 25mg/ml SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 03 October 2017 till 02 October 2022

POM

1613 BRU17082240P Canesten HC Cream Clotrimazole 1% w/w; Hydrocortisone 1% w/w

Kern Pharma S.L., Spain Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02 October 2022

P

BDMCA/RMP/1220 Page 113 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1614 BRU17082241P HOE’s Milk Of Magnesia Oral Suspension 800mg/5ml

Magnesium Hydroxide 800mg/5ml HOE Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 03 October 2017 till 02 October 2022

GSL

1615 BRU17082242P Losartan Hexal 50mg film-coated tablets

Losartan potassium 50mg equivalent to Losartan 45.76mg

Sandoz IIAC Sanayi ve Ticaret A.S., Turkey

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02 October 2022

POM

1616 BRU17082243P Losartan Hexal 100mg film-coated tablets

Losartan potassium 100mg equivalent to Losartan 91.52mg

Sandoz IIAC Sanayi ve Ticaret A.S., Turkey; Sandoz Grup Saglik Ürünleri Ilaclari Sanayi, Turkey

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02 October 2022

POM

1617 BRU17092244P RELVAR ELLIPTA 100/25 MICROGRAMS INHALATION POWDER, PRE-DISPENSED

Pre-dispensed dose of 100micrograms of fluticasone furoate and 25 micrograms of vilanterol (as trifenatate).*Each inhalation of the product provides a delivered dose of 92mcg of fluticasone furoate and 22mcg of vilanterol (trifenatate)

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), UK

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02 October 2022

POM

1618 BRU17092245P RELVAR ELLIPTA 200/25 MICROGRAMS INHALATION POWDER, PRE-DISPENSED

Pre-dispensed dose of 200micrograms of fluticasone furoate and 25 micrograms of vilanterol (as trifenatate).*Each inhalation of the product provides a delivered dose of 184mcg of fluticasone furoate and 22mcg of vilanterol (trifenatate)

Glaxo Operations UK Ltd (trading as Glaxo Wellcome Operations), UK

Zuellig Pharma (B) Sdn Bhd 03 October 2017 till 02 October 2022

POM

1619 BRU17092246P HIPROGIN INJECTION 250MG/ML (1 ML AMPOULE)

Hydroxyprogesterone caproate 250mg/ml

Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading Co 03 October 2017 till 02 October 2022

POM

1620 BRU17092247P Phebra Magnesium Sulfate Heptahydrate 50% 2.5g/5mL

Magnesium Sulfate Heptahydrate 500mg/Ml

Phebra Pty Ltd, Australia G&H trading Co 03 October 2017 till 02 October 2022

POM

1621 BRU17092248P Phebra Magnesium Sulfate Heptahydrate 50% 5g/10mL

Magnesium Sulfate Heptahydrate 500mg/Ml

Phebra Pty Ltd, Australia G&H Trading Co 03 October 2017 till 02 October 2022

POM

1622 BRU17092249NP Yellow Balsem Three Legs Brand Ointment

Methylsalicylate 13.5% w/wMenthol 7.5% w/wCamphor 7% w/w

Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 03 October 2017 till 02 October 2022

GSL

BDMCA/RMP/1220 Page 114 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1623 BRU17092251NP ORS PLUS Each sachet contains the equivalent of:Sodium chloride 650 mgPotassium chloride 375 mgTrisodium citrate 725 mgGlucose Anhydrous 3.375 g

Pharmaniaga Manufacturing Berhad, Malaysia

G&H Trading Company 03 October 2017 till 02 October 2022

GSL

1624 BRU17092252NP Axe Brand Universal Oil i) Menthol crystals 20% w/wii) Camphor 5% w/wiii) Eucalyptus Oil 15% w/wiv) Methyl salicylate 15% w/w

Leung Kai Fook Medical Co Pte Ltd., Singapore

Yuh Hua Trading Company 03 October 2017 till 02 October 2022

GSL

1625 BRU17092253NP Vitabiotics Pregnacare breast-feeding Tablet/Capsule

Vitamins & Minerals; Omega-3 Fish Oil (For detailed formulation referred to dossier)

Tablets:Thompson and Capper, UKCapsule:EuroCaps Limited, UK

Rico Agencies 03 October 2017 till 02 October 2022

GSL

1626 BRU17092254P Ravimed Tablet 5mg Medroxyprogesterone acetate USP 5mg

Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 03 October 2017 till 02 October 2022

POM

1627 BRU17092255P Prazosin 2mg Tablet Prazosin HCl 2.190mg equivalent to Prazosin 2mg

T.O. Pharma Co., Ltd., Thailand Medicorp Sdn Bhd 03 October 2017 till 02 October 2022

POM

1628 BRU17092256P Vaxcel Acyclovir 250mg I.V. for Infusion

Acyclovir Sodium equivalent to Acyclovir 250mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 03 October 2017 till 02 October 2022

POM

1629 BRU17112257P Azithromycin Tablets 250mg Azithromycin Dihydrate equivalent to Azithromycin 250mg

Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26 February 2023

POM

1630 BRU17112258P Fybogel Orange Sachet Ispaghula Husk BP 3.5g Reckitt Benckiser Healthcare (UK) Ltd., UK

Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26 February 2023

GSL

1631 BRU17112259NP Paracetamol Osteo-Tab Modified Release Tablets

Paracetamol 665mg Macleods Pharmaceuticals Ltd, India

Medipharm Sdn Bhd 27 February 2018 till 26 February 2023

P

1632 BRU17112260P Phenadryl Syrup Each 5ml contains: i) Diphenhydramine Hydrochloride 14mgii) Ammonium Chloride 135mgiii) Sodium Citrate 57.5mg

Y.S.P. Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 27 February 2018 till 26 February 2023

POM

1633 BRU17112261P Dermosone Cream 0.1% Betamethasone (as Valerate) 0.1% w/w Winwa Medical Sdn Bhd, Malaysia

Medicorp Sdn Bhd 27 February 2018 till 26 February 2023

POM

BDMCA/RMP/1220 Page 115 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1634 BRU17112262P Regpara® TABLETS 25MG Cinacalcet hydrochloride 27.55mg eqv to Cinacalcet 25mg

Ohara Pharmaceutical Co., Japan [ secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

K-Seri Pharma Sdn Bhd 27 February 2018 till 26 February 2023

POM

1635 BRU17112263PS1 & BRU17112263PS2

Octagam 2.5g in 50ml Human Normal Immunoglobulin (IVIg)* 50mg/ml*corresponding to the total protein content of which at least 95% is human Immunoglobulin G

1. Octapharma S.A.S., 72 rue du Marêchal Foch 67380 Lingolsheim, France (Manufacturing, packaging, batch release, storage and distribution)2. Octapharma Pharmazeutika Produktionsges.m.b.H, Oberlaaer Straβe 235 1100 Vienna, Austria (Manufacturing, packaging testing, batch certification)3. Octapharma GmbH, Niederlassung Dessau, Otto-Reuter- Straβe 3, Gemaβ den Lageplanen Nr. 1 bis Nr. 3, 06847 Dessau-Roβlau, Saxony-Anhalt, Germany (Additional packaging

G&H Trading Sdn Bhd 27 February 2018 till 26 February 2023

POM

1636 BRU17122264P Ceficad 1000mg injection Cefepime Hydrochloride USP eq to Cefepime 1000mg

Cadila Pharmaceuticals Limited, India

K-Seri Pharma 27 February 2018 till 26 February 2023

POM

1637 BRU17122265P Probitor capsule 20mg Omeprazole 20mg Lek Pharmaceuticals d.d., SloveniaZuellig Pharma Sdn Bhd 27 February 2018 till 26 February 2023

POM

1638 BRU17122266P Solbid tablet 10mg Isosorbide Dinitrate 10mg SM Pharmaceuticals Sdn Bhd, MalG & H Trading Company 27 February 2018 till 26 February 2023

POM

1639 BRU17122267NP Adelim Ringworm Solution Tolnaftate 1% w/v Syarikat Wen Ken Drug Sdn Bhd, MSyarikat Rajamas Bersama 27 February 2018 till 26 February 2023

GSL

1640 BRU17122268P Converium 300mg Tablet Irbesartan 300mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 27 February 2018 till 26 February 2023

POM

1641 BRU17122269P Salazine Enteric Coated Tablet 5Sulfasalazine 500mg Sriprasit Pharma Co. Ltd., ThailandMedicorp Sdn Bhd 27 February 2018 till 26 February 2023

POM

1642 BRU17122270P Axcel Metronidazole-200 TabletMetronidazole 200mg Kotra Pharma (M) Sdn Bhd, MalayMedicorp Sdn Bhd 27 February 2018 till 26 February 2023

POM

1643 BRU17122271NP Dermorub Liniment Muscle & JoMethyl salicylate 25% v/v Winwa Medical Sdn. Bhd., MalaysMedicorp Sdn Bhd 27 February 2018 till 26 February 2023

GSL

BDMCA/RMP/1220 Page 116 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1644 BRU17122272P Tenof 300mg tablet Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir Disoproxil 245mg

Hetero Labs Limited,India K-Seri Pharma Sdn Bhd 27 February 2018 till 26 February 2023

POM

1645 BRU17122273NP Bisacodyl Tablets 5mg Bisacodyl 5mg Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 27 February 2018 till 26 February 2023

P

1646 BRU17122274P Alfutor ER Tablets 10mg Alfuzosin Hydrochloride 10mg Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 27 February 2018 till 26 February 2023

POM

1647 BRU17122275P Venlift ER 37.5mg Capsule Venlafaxine Hydrochloride equivalent to Venlafaxine 37.5mg

Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 27 February 2018 till 26 February 2023

POM

1648 BRU17122276P Venlift ER 75mg Capsule Venlafaxine Hydrochloride equivalent to Venlafaxine 75mg

Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 27 February 2018 till 26 February 2023

POM

1649 BRU17122277P Venlift ER 150mg Capsule Venlafaxine Hydrochloride equivalent to Venlafaxine 150mg

Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 27 February 2018 till 26 February 2023

POM

1650 BRU17122278NP Rohto C Cube Eye Drops Per 100mL contains: Potassium Chloride 0.08g; Sodium Chloride 0.44g; Hydroxyethylcellulose 0.07g

Rohto Pharmaceutical Co., Ltd., Japan

Hamitan Marketing 27 February 2018 till 26 February 2023

GSL

1651 BRU17122279P Medaxonum (Ceftriaxone) 1G Powder for Injection for Infusion

Ceftriaxone sodium eq. to ceftriaxone 1G

Medochemie Ltd., Cyprus Medicorp Sdn Bhd 27 February 2018 till 26 February 2023

POM

1652 BRU17122281NP Konsyl Original Formula Psyllium Fiber

Psyllium Hydrophilic Mucilloid Husk 6g/dose

Konsyl Pharmaceuticals, Inc., USA

MediPharm Sdn Bhd 27 February 2018 till 26 February 2023

GSL

1653 BRU17122282P VAXCEL CEFOBACTAM-1G INJECTION

Cefoperazone sodium eq. to cefoperazone 500mg; Sulbactam sodium eq. to Sulbactam 500mg

Kotra Pharma (M) Sdn Bhd., Malaysia

Medicorp Sdn Bhd 27 February 2018 till 26 February 2023

POM

1654 BRU17122283P Ibuspan Tablet 200mg Ibuprofen 200mg SM Pharmacetuicals Sdn Bhd, Malaysia

G & H Trading Company 27 February 2018 till 26 February 2023

P

1655 BRU17122284NP Ubat Sembelit Cap Kaki Tiga Per 5ml: Magnesium sulphate 1.77g Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 27 February 2018 till 26 February 2023

GSL

1656 BRU17122285P Fucithalmic Eye Drops 1% Fusidic acid 10mg/g LEO Laboratories Limited, Ireland DCH Auriga (Borneo) Sdn Bhd 27 February 2018 till 26 February 2023

POM

1657 BRU17122286NP SM Calamine Lotion i) Calamine 15%w/v; ii) Zinc Oxide 5% w/v

SM Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 27 February 2018 till 26 February 2023

GSL

1658 BRU17122287P Pivakan 0.5% w/v (plain) Injection (20ml Vial)

Bupivacaine HCl Monohydrate equivalent to Bupivacaine HCl 5mg/ml

Duophrma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 27 February 2018 till 26 February 2023

POM

1659 BRU18012288P Irbesartan Tablets 150mg Irbesartan 150mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26 February 2023

POM

1660 BRU18012289P Irbesartan Tablets 300mg Irbesartan 300mg Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 27 February 2018 till 26 February 2023

POM

1661 BRU18012290P Travocort Cream Isoconazole nitrate (10mg/g): Diflucortolone valerate (1mg/1g)

LEO Pharma Manufacturing Italy S.r.I, Italy

Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26 February 2023

POM

BDMCA/RMP/1220 Page 117 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1662 BRU18012291P Spiolto Respimat Inhalation Solution 2.5μg/2.5μg per actuation

Per actuation: 2.5mg Tiotropium (as bromide monohydrate) and 2.5mg Olodaterol (as hydrochloride)

Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 27 February 2018 till 26 February 2023

POM

1663 BRU18012292P Zykadia™ 150mg Hard Capsule Ceritinib 150mg Novartis Pharma AG, Switzerland Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26 February 2023

POM

1664 BRU18012293P Synagis 100mg/ml Solution for Injection

Palivizumab 100mg/ml Boehringer Ingelheim Pharma GmbH & Co. KG, Germany [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26 February 2023

POM

1665 BRU18012294NP Ketosteril Film-Coated Tablet Calcium-3-methyl-2-oxo-valerate (α–Ketoanologue to Isoleucine, calcium salt) 67 mg;Calcium-4-methyl-2-oxo-valerate (α–Ketoanologue to Leucine, calcium salt) 101 mg;Calcium-2--oxo-3-phenyl-propionate (α–Ketoanologue to Phenylalanine, calcium salt) 68 mg;Calcium-3-methyl-2-oxo-butyrate (α–Hydroxyanalogue to Valine, calcium salt) 86 mg;Calcium-DL-2-hydroxyl-4-(methyl-thio)butyrate (α–Hydroxyanalogue to Methionine, calcium salt) 59 mg;L-Lysine acetate (= 75mg L-Lysine) 105 mg;L-Threonine 53 mg;L-Tryptophan 23 mg;L-Histidine 38 mg;L-Tyrosine 30 mg;

Labesfal-Laboratorios Almiro S.A., Portugal

Zuellig Pharma (B) Sdn Bhd 27 February 2018 till 26 February 2023

POM

1666 BRU18012295PS1; BRU18012295PS2

Kadcyla Powder for Coencentrate for Solution for Infusion 100mg/vial

Trastuzumab emtansine 100mg Patheon, Manufacturing Services, LLC, USA (S1); F. Hoffmann-La Roche Ltd, Switzerland (S2)

MediPharm Sdn Bhd 27 February 2018 till 26 February 2023

POM

1667 BRU18012296PS1; BRU18012296PS2

Kadcyla Powder for Coencentrate for Solution for Infusion 160mg/vial

Trastuzumab emtansine 160mg Patheon, Manufacturing Services, LLC, USA (S1); F. Hoffmann-La Roche Ltd, Switzerland (S2)

MediPharm Sdn Bhd 27 February 2018 till 26 February 2023

POM

BDMCA/RMP/1220 Page 118 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1668 BRU18012297NP 5% DEXTROSE IN WATER SOLUTION FOR INTRAVENOUS INFUSION

Dextrose monohydrate 5% Euro-Med Laboratories Phil Inc, Philippines

Medicorp Sdn Bhd 27 February 2018 till 26 February 2023

GSL

1669 BRU18012298NP 10% DEXTROSE IN WATER SOLUTION FOR INTRAVENOUS INFUSION

Dextrose monohydrate 10% Euro-Med Laboratories Phil Inc, Philippines

Medicorp Sdn Bhd 27 February 2018 till 26 February 2023

GSL

1670 BRU18012299P THREE LEGS TINEA-KARE ANTI-FUNGAL CREAM 1%W/W

Clotrimazole 1% w/w Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 27 February 2018 till 26 February 2023

GSL

1671 BRU18012300P Airlukast Chewable Tablets 5mg

Montelukast sodium 5.187mg (eq. to Montelukast 5mg)

Ranbaxy (Malaysia) Sdn Bhd, Malaysia

MediPharm Sdn Bhd 27 February 2018 till 26 February 2023

POM

1672 BRU18012301NP Gascoal Tablet 50mg Dimethylpolysiloxane 50mg Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 27 February 2018 till 26 February 2023

GSL

BDMCA/RMP/1220 Page 119 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1673 BRU18012302NP Vitabiotics Pregnacare Original Tablet

Natural Mixed Carotenoids (as Natural Betacarotene 20% CWD Powder 10.0 mg) 2.00 mg;Thiamin (Vitamin B1) (as Thiamine Mononitrate 3.7 mg) 3.00 mg;Riboflavin (Vitamin B2) (as Riboflavin 2.0 mg) 2.00 mg;Vitamin D3 (as Vitamin D3 100 IU/mg EC 4.0 mg) 10.00 µg;Folacin (Folic Acid) (as Folic Acid 400.0 µg) 400.00 µg;Vitamin K (as Vitamin K1 5% GFT (BASF) 1.4 mg) 70.00 µg;Vitamin B12 (as Cyanocobalamin 0.1% DCP Prep. 6.0 mg) 6.00 µg;Vitamin B6 (as Pyridoxine Hydrochloride 12.2 mg) 10.00 mg;Pantothenic Acid (as Calcium D-Pantothenate 6.5 mg) 6.00 mg;Biotin (as D-Biotin 150.0 µg) 150.00 µg;Vitamin C (as Ascorbic Acid HPMC (97%) 72.2 mg) 70.00 mg;Vitamin E (as D alphaTocopheryl Acid Succinate 24.6 mg) 20.00 mg;Niacin (Vitamin B3) (as Nicotinamide 20.0 mg) 20.00 mg;Zinc (as Zinc Sulphate Monohydrate 41.2 mg) 15.00 mg;Iron (as Ferrous Fumarate 51.7 mg) 17.00 mg;

Brunel Healthcare Manufacturing Limited, UK

Rico Agencies 27 February 2018 till 26 February 2023

GSL

1674 BRU18022303NP Glycophos Concentrate for Solution for Infusion

Sodium glycerophosphate pentahydrate 306.1mg/ml corresponds to 216mg sodium glycerophosphate

Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

P

BDMCA/RMP/1220 Page 120 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1675 BRU18022304NP Nutrilite Daily Tablet

Nutrilite concentrate 527.84mg; Dicalcium phosphate 447.58mg; Ascorbic acid 125.96mg; Ferrous fumarate 57.37mg; d-alpha-tocopheryl acid succinate 32.21mg; Niacinamide 23.99mg; Zinc oxide 21.55mg; Copper gluconate 16.44mg; Calcium stearate 20.48mg; Corn starch 15.34mg; Talc 15.00mg; D-calcium panthothenate 13.88mg; Sucrose 13.12mg; Fish gelatin 10.80mg; Sodium carboxymethylcellulose 10.39mg; Lactose 9.8mg; Magnesium oxide 8.62mg; Hydroxypropyl methylcellulose 8.01mg; PolyvInylpyrrolidone 5.28mg; Vitamin A Palmitate 5.00mg; Pyridoxine Hydrochloride 3.64mg; Riboflavin 2.99mg; Thiamine mononitrate 2.79mg; Glycerin 0.80mg; Folic acid 0.64mg; Potassium iodide 0.27mg; Carnauba wax 0.08mg; Vitamin D3 0.02mg ; Cyanocobalamin 0.002mg

Access Business Group LLC, USA Amway (B) Sdn Bhd 06 June 2018 till 05 June 2023

GSL

1676 BRU18022305P Flutiform 50 microgram/5 microgram Per Actuation Pressurised Inhalation Suspension

Each metered dose (ex-valve) contains:

50mcg of fluticasone propionate and 5mcg of formeterol fumarate dihydrate,

This is equivalent to a delivered dose (ex-actuator) of approximately 46 mcg of fluticasone propionate/ 4.5mcg of formoterol fumarate dihydrate.

Recipharm HC Limited, UK Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

BDMCA/RMP/1220 Page 121 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1677 BRU18022306P Flutiform 250 microgram/10 microgram Per Actuation Pressurised Inhalation Suspension

Each metered dose (ex-valve) contains:

250mcg of fluticasone propionate and 10mcg of formeterol fumarate dihydrate,

This is equivalent to a delivered dose (ex-actuator) of approximately 230 mcg of fluticasone propionate/ 9.0mcg of formoterol fumarate dihydrate.

Recipharm HC Limited, UK Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1678 BRU18022307P Flutiform 125 microgram/5 microgram Per Actuation Pressurised Inhalation Suspension

Each metered dose (ex-valve) contains:

125mcg of fluticasone propionate and 5mcg of formeterol fumarate dihydrate,

This is equivalent to a delivered dose (ex-actuator) of approximately 115 mcg of fluticasone propionate/ 4.5mcg of formoterol fumarate dihydrate.

Recipharm HC Limited, UK Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1679 BRU18022308P Jakavi 10mg tablet Ruxolitinib phosphate 13.2mg eq. to 10mg Ruxolitinib

Novartis Pharma Stein, AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1680 BRU18022309P Zycort Injection 100mg Each vial contains Hydrocortisone Sodium Succinate BP equivalent to Hydrocortisone 100mg

SM Pharmaceuticals Sdn Bhd., Malaysia

G&H Trading Company 06 June 2018 till 05 June 2023

POM

1681 BRU18022310P; BRU18022310PS2

Opsumit 10mg Film-coated Tablet

Macitentan 10mg Patheon Italia S.p.A., Italy; Excella GmbH & Co. KG., Germany (S2) [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd, Singapore)

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1682 BRU18022311P URACTONUM 25MG TABLET Spironolactone 25mg Medochemie Ltd., Cyprus Hongkiat Trading & Company 06 June 2018 till 05 June 2023

POM

1683 BRU18022312P Perjeta Concentrate for Solution for Infusion 420mg/14ml

Pertuzumab 420mg Roche Diagnostics GmbH, Germany

Medipharm Sdn Bhd 06 June 2018 till 05 June 2023

POM

BDMCA/RMP/1220 Page 122 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1684 BRU18022313P Cefepime-AFT Powder for Injection 1G

Cefepime Hydrochloride equivalent to Cefepime 1G

Qilu Pharmaceutical Co. Ltd., P.R. China

Medipharm Sdn Bhd 06 June 2018 till 05 June 2023

POM

1685 BRU18022314NP Renal-Sol® A1 Each litre of concentrate contains:Sodium Chloride BP 161.43gPotassium Chloride BP 5.50gCalcium Chloride 2H2O BP 9.74gMagnesium Chloride 6H2O BP 3.74gGlacial Acetic Acid BP 8.84gHighly Purified Water BP 1000mL

Renal Laboratories Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June 2023

GSL

1686 BRU18022315NP Renal-Sol® A3 Each litre of concentrate contains:Sodium Chloride BP 161.43gPotassium Chloride BP 5.50gCalcium Chloride 2H2O BP 6.75gMagnesium Chloride 6H2O BP 3.74gGlacial Acetic Acid BP 8.84gHighly Purified Water BP 1000mL

Renal Laboratories Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June 2023

GSL

1687 BRU18022316P Celecoxib Sandoz Capsule 200mg

Celecoxib 200mg Lek Pharmaceuticals d.d., Slovenia

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1688 BRU18022317NP Microshield® 2 Chlorhexidine Skin Cleanser

Chlorhexidine Gluconate 2% w/v Ensign Laboratories Pty Ltd., Australia

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

GSL

1689 BRU18022318NP Sangobion Capsule Each capsule contains:Ferrous Gluconate 250mgManganese sulphate 0.2mgCopper sulphate 0.2mgVitamin C 50.0mgFolic acid 1.0mgVitamin B12 7.5mcg

PT. Merck Tbk, Indonesia Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

GSL

1690 BRU18022319P Talgesil Injection 0.1mg/2ml (Amp)

Fentanyl 0.1mg/2ml Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June 2023

POM

1691 BRU18032320P Norfox tablet Norfloxacin 400mg The United Drug (1996) Co. Ltd., Thailand

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

POM

1692 BRU18032321P Domil Suspension 5mg/5ml Domperidone 5mg/5ml Noripharma Sdn Bhd, Malaysia Asterix United (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1693 BRU18032322P Latanostill 50mcg/ml Eye Drops Solution

Latanoprost 50 mcg/ml Bruschettini s.r.I., Italy Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

POM

BDMCA/RMP/1220 Page 123 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1694 BRU18032323P Gardasil 9, suspension for injection

Each 0.5mL dose contains:HPV Type 6 L1 Protein….. 30 μg HPV Type 11 L1 Protein….40 μg HPV Type 16 L1 Protei.…. 60 μg HPV Type 18 L1 Protein….40 μg HPV Type 31 L1 Protein.... 20 μg HPV Type 33 L1 Protein… 20 μg HPV Type 45 L1 Protein… 20 μg HPV Type 52 L1 Protein… 20 μgHPV Type 58 L1 Protein… 20 μg

Merck Sharp & Dohme Corp., USA

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1695 BRU18032324P Entresto 50mg Film-coated Tablets

Sacubitril 24.3 mg & Valsartan 25.7 mg Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1696 BRU18032325P Entresto 100mg Film-coated Tablets

Sacubitril 48.6 mg & Valsartan 51.4 mg Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1697 BRU18032326P Entresto 200mg Film-coated Tablets

Sacubitril 97.2 mg & Valsartan 102.8 mg

Novartis Singapore Pharmaceutical Manufacturing Pte Ltd, Singapore

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1698 BRU18032327P Dyna Amoxycillin 125mg/5ml Amoxycillin (as trihydrate) 125mg/5ml Dynapharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

POM

1699 BRU18032328P Winofen suspension 2% w/v Ibuprofen 100mg/5ml Winwa Medical Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

P

1700 BRU18032329P Wincort 1% cream Hydrocortisone acetate 1% w/w Winwa Medical Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

P

1701 BRU18032330P Acugesic Tablet 50mg Tramadol HCl 50mg Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June 2023

POM

1702 BRU18032331NP Microshield® Handrub Solution

Chlorhexidine Gluconate 0.5% w/v in Ethanol 70% v/v

Ensign Laboratories Pty Ltd., Australia

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

GSL

1703 BRU18032332P Defuzin Cream 2% w/w Fusidic acid 2% w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 June 2018 till 05 June 2023

POM

1704 BRU18032333P Hydrochlorzide-50 Tablet Hydrochlorothiazide 50mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 June 2018 till 05 June 2023

POM

1705 BRU18032334P SIMBRINZA* 10 mg/ml + 2 mg/ml eye drops, suspension

1 ml of suspension contains 10 mg of Brinzolamide and 2 mg of Brimonidine tartrate equivalent to 1.3 mg of Brimonidine

Alcon-Couvreur N.V., Belgium Medipharm Sdn Bhd 06 June 2018 till 05 June 2023

POM

BDMCA/RMP/1220 Page 124 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1706 BRU18032335NP Hexidin Cream 1% Chlorhexidine Gluconate 1% w/w Noripharma Sdn Bhd, Malaysia G&H Trading Company 06 June 2018 till 05 June 2023

GSL

1707 BRU18032336NP Green Balsem, Three Legs Brand

Menthol........... 10% w/wCamphor......... 4% w/w

Syarikat Wen Ken Drug Sdn Bhd., Malaysia

Syarikat Rajamas Bersama 06 June 2018 till 05 June 2023

GSL

1708 BRU18042337P DUAVIVE 20MG/0.45MG MODIFIED-RELEASE TABLETS Bazedoxifene acetate equivalent to

20mg bazedoxifene; and Conjugated estrogens 0.45mg.

Pfizer Ireland Pharmaceuticals, Ireland

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1709 BRU18042338P Novatretin™ 25mg Capsules Acitretin 25mg Micro-Sphere S.A., Switzerland K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June 2023

POM

1710 BRU18042339P Novatretin™ 10mg Capsules Acitretin 10mg Micro-Sphere S.A., Switzerland K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June 2023

POM

1711 BRU18042340P Axcel Metoclopramide Tablet Metoclopramide Hydrochloride equivalent to Anhydrous Metoclopramide Hydrochloride 10mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

POM

1712 BRU18042341P TADIM Colistimethate Sodium 1 Million IU Powder for Nebuliser Solution Vial

Colistimethate Sodium 1 Million IU Xellia Pharmaceuticals ApS, Denmark

G&H Trading Company 06 June 2018 till 05 June 2023

POM

1713 BRU18042342P Clovix 75mg tablet Clopidogrel hydrogen sulphate 97.875mg (eq. to clopidogrel 75mg)

China Chemical & Pharmaceutical Co. Ltd., R.O.C., Taiwan

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

POM

1714 BRU18042343P AXCEL CETIRIZINE TABLET Cetirizine dihydrochloride 10mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

P

1715 BRU18042344P; BRU18042344PS2

Zarzio 30 MU/0.5ml Solution for Injection or Infusion in Pre-filled Syringe

30 million units (equivalent to 300mcg) filgrastim in 0.5ml

IDT Biologika GmbH, Germany; Sandoz GmbH, Austria

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1716 BRU18042345P Ibrance Capsules 75mg Palbociclib 75mg Pfizer Manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1717 BRU18042346P Ibrance Capsules 100mg Palbociclib 100mg Pfizer Manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1718 BRU18042347P Ibrance Capsules 125mg Palbociclib 125mg Pfizer Manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1719 BRU18042348P TULIP® 40MG FILM-COATED TABLET

Atorvastatin (as Atorvastatin calcium) 40mg

Lek Pharmaceuticals d.d , Solvenia

Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

BDMCA/RMP/1220 Page 125 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1720 BRU18062349P Victoza® 6mg/ml, Solution for Injeciton in Pre-filled Pen

Liraglutide 6mg/ml Novo Nordisk A/S, Denmark Zuellig Pharma (B) Sdn Bhd 06 June 2018 till 05 June 2023

POM

1721 BRU18062350P AXCEL CLINDAMYCIN TOPICAL SOLUTION 1% W/V

Clindamycin Phosphate 1% Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

POM

1722 BRU18062351P Flucon Solution for IV Infusion 2mg/ml

Fluconazole 2mg/ml Siu Guan Chem. Ind., Taiwan K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June 2023

POM

1723 BRU18062352P ANALPAN INJECTION 75MG/3ML

Diclofenac Sodium 75mg/3ml Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 06 June 2018 till 05 June 2023

POM

1724 BRU18062353P ELIGARD® Powder and Solvent for Solution for Injection 7.5mg

Leuprorelin Acetate 7.5 mg (equivalent to 6.96 mg leuprorelin) (syringe B)Solvent (Syringe A):Poly(DL-lactic-co-glycolic-acid) (50:50) and N-methylpyrrolidine

Tolmar Inc., USA Medipharm Sdn Bhd 06 June 2018 till 05 June 2023

POM

1725 BRU18062354P ELIGARD® Powder and Solvent for Solution for Injection 22.5mg

Leuprorelin Acetate 22.5 mg (equivalent to 20.87 mg leuprorelin) (syringe B)Solvent (Syringe A):Poly(DL-lactic-co-glycolic-acid) (75:25) and N-methylpyrrolidine

Tolmar Inc., USA Medipharm Sdn Bhd 06 June 2018 till 05 June 2023

POM

1726 BRU18062355P ELIGARD® Powder and Solvent for Solution for Injection 45mg

Leuprorelin Acetate 45 mg (equivalent to 41.7 mg leuprorelin) (syringe B) Solvent (Syringe A):Poly(DL-lactic-co-glycolic-acid) (85:15) and N-methylpyrrolidine

Tolmar Inc., USA Medipharm Sdn Bhd 06 June 2018 till 05 June 2023

POM

1727 BRU18062356P THREE LEGS TINEA-KARE ANTI-FUNGAL SPRAY 1% W/V

Clotrimazole 1% w/v Syarikat Wen Ken Drug Sdn. Bhd., Malaysia

Syarikat Rajamas Bersama 06 June 2018 till 05 June 2023

GSL

1728 BRU18062357NP Potrelease TR Tablet 600mg Potassium Chloride 600mg SM Pharmaceuticals Sdn Bhd., Malaysia

G&H Trading Company 06 June 2018 till 05 June 2023

P

BDMCA/RMP/1220 Page 126 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1729 BRU18062358NP Renal-Sol® A3 + G Each litre of concentrate contains:Sodium Chloride BP 161.43gPotassium Chloride BP 5.50gCalcium Chloride 2H2O BP 6.75gMagnesium Chloride 6H2O BP 3.74gGlacial Acetic Acid BP 8.84gDextrose H20 73.00gHighly Purified Water BP 1000mL

Renal Laboratories Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 06 June 2018 till 05 June 2023

GSL

1730 BRU18062359P Encardil Tablet 10mg Enalapril Maleate 10mg SM Pharmaceuticals Sdn Bhd., Malaysia

G&H Trading Company 06 June 2018 till 05 June 2023

POM

1731 BRU18062360NP Microshield® 4 Chlorhexidine Surgical Handwash

Chlorhexidine Gluconate 4% w/v (equivalent to Chlorhexidine 22.5g/L)

Ensign Laboratories Pty Ltd., Australia

Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

GSL

1732 BRU18062361P Pharmaniaga Ranitidine Tablet 150mg

Ranitidine (as hydrochloride) 150mg Pharmaniaga Manufacturing Berhad, Malaysia

G&H Trading Company 06 June 2018 till 05 June 2023

POM

1733 BRU18062362P Apo-Carvedilol 6.25mg Tablet Carvedilol 6.25mg Apotex Inc, Canada Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

POM

1734 BRU18062363P Apo-Carvedilol 25mg Tablet Carvedilol 25mg Apotex Inc, Canada Medicorp Sdn Bhd 06 June 2018 till 05 June 2023

POM

1735 BRU18062364P Cef-3 Injection IM (500mg) Powder - Ceftriaxone (as disodium) 500mg

Diluent – Lidocaine HCl 1%

Siam Bheasach Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 05 September 2018 till 04 September 2023

POM

1736 BRU18062365P Simponi Solution for Injection 100mg/1.0ml

Golimumab 100mg/1.0ml Baxter Pharmaceutical Solutions LLC, United States

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04 September 2023

POM

1737 BRU18062366P Apo-Atorvastatin 20mg tablet Atorvastatin calcium propylene glycol solvate USP 22mg eq. to 20mg atorvastatin

Apotex Inc., Canada Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

POM

1738 BRU18062367P Apo-Atorvastatin 40mg tablet Atorvastatin calcium propylene glycol solvate USP 42mg eq. to 40mg atorvastatin

Apotex Inc., Canada Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

POM

1739 BRU18062368NP Sodium Chloride Parenteral Solution 0.9%

Each 100ml contains Sodium Chloride 900mg

Euro-Med Laboratories Phil., Philippines

Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

GSL

BDMCA/RMP/1220 Page 127 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1740 BRU18062369NP Lactated Ringer’s Solution Each 100ml contains: Sodium Chloride 600mg Sodium Lactate Anhydrous 310mg Potassium Chloride 30mg Calcium Chloride Dihydrate 20mg

Euro-Med Laboratories Phil., Philippines

Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

GSL

1741 BRU18062370NP Optrex Refreshing Eye Drops Hamamelis Water (Witch Hazel) 13.0% v/v

Reckitt Beckinser Healthcare International Ltd, UK

Syarikat Aliaa Sdn Bhd 05 September 2018 till 04 September 2023

GSL

1742 BRU18062371P Codipront Capsules Codeine base 30mg (as Codeine phosphate hemihydrate); Phenyltoloxamine base 10mg (as Phenyltoloxamine citrate)

CTS Chemical Industries Ltd, Israel

Hongkiat Trading & Company 05 September 2018 till 04 September 2023

POM

1743 BRU18062372PS1, BRU18062372PS2 & BRU18062372PS3

Mixtard® 30 Penfill® 100 IU/ml, 3ml Cartridge Suspension for Injeciton

1ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA) (30% as soluble insulin and 70% as isophane insulin)

1. Novo Nordisk A/S, Denmark (S1)2. Novo Nordisk Production SAS, France (S2)3. Novo Nordisk Producão, Brazil (S3)

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04 September 2023

POM

1744 BRU18072373P Apo-Ranitidine 150mg Tablet Ranitidine 150mg Apotex Inc, Canada MediPharm Sdn Bhd 05 September 2018 till 04 September 2023

POM

1745 BRU18072374P Axcel Iridin Linctus Pholcodine 10mg/5ml Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

POM

1746 BRU18072375P Dynalexin Dry Syrup 125mg/5ml

Cephalexin monohydrate 130mg eq to 125mg cephalexin per 5ml

Dynapharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

POM

1747 BRU18072376P Aspira Tablet 10mg Montelukast sodium 10.40mg equivalent to montelukast 10mg

Pharmaniaga Manufacturing Berhad, Malaysia

G&H Trading Company 05 September 2018 till 04 September 2023

POM

1748 BRU18072377P Terbin Cream 1% Terbinafine Hydrochloride 10mg/g SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 05 September 2018 till 04 September 2023

GSL

1749 BRU18072378NP Eagle Brand Medicated Oil Aromatic, Lavender & Eucalyptus

i) Menthol 16.0% w/wii) Methyl Salicylate 35.0% w/wiii) Eucalyptus Oil 17.5% w/wiv) Camphor 7.0% w/w

Borden Company (Private) Limited, Singapore

SP Setia Sdn Bhd 05 September 2018 till 04 September 2023

GSL

BDMCA/RMP/1220 Page 128 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1750 BRU18072379P Eye Glo Plus Eye Drops i) Boric Acid 1.3% w/vii) Borax 0.3% w/viii) Distilled Witch Hazel 5% w/v

Duopharma (M) Sdn Bhd, Malaysia

Bintang Ria Sdn Bhd 05 September 2018 till 04 September 2023

GSL

1751 BRU18072380NP Crotocort Cream 10% w/w Crotamiton 10% w/w SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 05 September 2018 till 04 September 2023

GSL

1752 BRU18072381P MabThera® Solution for Subcutaneous Injection 1400mg

Rituximab 120mg/mL F. Hoffmann-LA Roche Ltd, Switzerland

MediPharm Sdn Bhd 05 September 2018 till 04 September 2023

POM

1753 BRU18082382P Tolanz ODT Tablets 5mg Olanzapine 5mg Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 05 September 2018 till 04 September 2023

POM

1754 BRU18082383P Tolanz ODT Tablets 10mg Olanzapine 10mg Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 05 September 2018 till 04 September 2023

POM

1755 BRU18082384NP BETADINE Gargle and Mouthwash

Povidone-Iodine 1% w/v PT Mahakam Beta Farma, Indonesia

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04 September 2023

GSL

1756 BRU18082385P Midazolam-Hameln 5mg/ml Injection, 1ml

Midazolam (as hydrochloride) 5mg/ml Siegfried Hameln GmbH, Germany

Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

POM

1757 BRU18082386P Optimol Eye Drops 0.5% Timolol Maleate 0.5% Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 05 September 2018 till 04 September 2023

POM

1758 BRU18082387P Niferin SR 30mg tablet Nifedipine 30mg China Chemical & Pharmaceutical Co. Ltd., R.O.C., Taiwan

Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

POM

1759 BRU18082388P Pharmaniaga Pethidine hydrochloride 50mg/1ml Injection

Pethidine hydrochloride 50mg/ml Pharmaniaga Lifescience Sdn Bhd, Malaysia

G&H Trading Company 05 September 2018 till 04 September 2023

POM

1760 BRU18082389P Pharmaniaga Pethidine hydrochloride 100mg/2ml Injection

Pethidine hydrochloride 100mg/2ml Pharmaniaga Lifescience Sdn Bhd, Malaysia

G&H Trading Company 05 September 2018 till 04 September 2023

POM

1761 BRU18082390P TAGRISSO 40MG FILM-COATED TABLETS

Osimertinib 40mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04 September 2023

POM

1762 BRU18082391P TAGRISSO 80MG FILM-COATED TABLETS

Osimertinib 80mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04 September 2023

POM

1763 BRU18082392P Adezio Tablet 10mg Cetirizine Hydrohloride 10mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd

Hongkiat Trading & Company 05 September 2018 till 04 September 2023

P

1764 BRU18082393P Enapril Tablet 20mg Enalapril Maleate 20mg Y.S.P. Industries (M) Sdn Bhd Asterix United (B) Sdn Bhd 05 September 2018 till 04 September 2023

POM

1765 BRU18082394P XALKORI 200MG HARD CAPSULES

Crizotinib 200mg Pfizer Manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04 September 2023

POM

1766 BRU18082395P XALKORI 250MG HARD CAPSULES

Crizotinib 250mg Pfizer Manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04 September 2023

POM

BDMCA/RMP/1220 Page 129 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1767 BRU18082396P Normaten Tablet 100mg Atenolol 100mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd

Hongkiat Trading & Company 05 September 2018 till 04 September 2023

POM

1768 BRU18082397P Brilinta 60mg Film-coated Tablet

Ticagrelor 60mg AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 05 September 2018 till 04 September 2023

POM

1769 BRU18082398P Atswift 10 Film Coated Tablets Atorvastatin Calcium Trihydrate equivalent to Atorvastatin 10mg

Ind-Swift Limited, India Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

POM

1770 BRU18082399P Atswift 20 Film Coated Tablets Atorvastatin Calcium Trihydrate equivalent to Atorvastatin 20mg

Ind-Swift Limited, India Medicorp Sdn Bhd 05 September 2018 till 04 September 2023

POM

1771 BRU18082400P Normaten Tablet 50mg Atenolol 50mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd

Hongkiat Trading & Company 05 September 2018 till 04 September 2023

POM

1772 BRU18082401P Adroten Tablet 5mg Bisoprolol Fumarate 5mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd

Hongkiat Trading & Company 05 September 2018 till 04 September 2023

POM

1773 BRU18092402P Mapenem (1G Injection) Meropenem trihydrate equivalent to Meropenem 1g and 208mg of anhydrous sodium carbonate)

Siam Bheasach Co., Ltd., Thailand

K-Seri Pharma Sdn. Bhd 11 December 2018 till 10 December 2023

POM

1774 BRU18092403P (With condition the porcine information is stated on the label)

Zostavax (Refrigerator Stable Formulation) Injection

Live attenuated Oka/Merck Varicella-Zoster Virus

Drug productMerck Sharp & Dohme, USA

DiluentVetter Pharma-Fertigung GmbH & Co. KG., Germany.

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1775 BRU18092404P Apo-Fluvoxamine 50mg tablet Fluvoxamine maleate 50mg Apotex Inc. Canada, Canada Medicorp Sdn. Bhd 11 December 2018 till 10 December 2023

POM

1776 BRU18092405P Ultiva Injection 5mg Each single use vial contains 5mg remifentanil (as hydrochloride).

GlaxoSmithKline Manufacturing, S.P.A., Italy.

Zuellig Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1777 BRU18092406P Ultravist 300 Injection 300mg/Ml

1ml contains 623mg iopromide (equivalent to 300mg iodine)

Bayer AG , Germany Zuellig Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1778 BRU18092407P Ultravist 370 Injection 370mg/Ml

1ml contains 769mg iopromide (equivalent to 370mg iodine)

Bayer AG , Germany Zuellig Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1779 BRU18092408P Halaven 0.5mg/ml Solution for Injection

Eribulin mesilate Biogen U.S. Corporation, USA. Medipharm Sdn Bhd 11 December 2018 till 10 December 2023

POM

1780 BRU18092409P Sivkort® Sterile Suspension for injection 40mg/1ml

Triamcinolone acetonide 40mg / 1ml Siu Guan Chem. Ind. Co. Ltd., Taiwan

K-Seri Pharma Sdn. Bhd. 11 December 2018 till 10 December 2023

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1781 BRU18092410P Dotarem 0.5 mmol/mL, Solution for Injection

Per 100 mL of solution:Gadoteric acid ……27.932 g Corresponding to:DOTA ……………20.246 gGadolinium oxide...9.062g

Contrast agent concentration: 0.5mmol/mL

Guerbet, France Manning Jaya Trading (B) Sdn Bhd

11 December 2018 till 10 December 2023

POM

1782 BRU18092411P Polytet Eye Ointment Each gram contains:Polymyxin B sulphate 6900 unit eq to Polymyxin B 6000 unitsOxytetracycline hydrochloride 5.94mg eq to Oxytetracycline 5mg

SM Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 11 December 2018 till 10 December 2023

POM

1783 BRU18092412P Latanoprost eye drops solution 0.005%w/v

Latanoprost 0.05mg/ml FDC Limited, India K-Seri Pharma Sdn. Bhd. 11 December 2018 till 10 December 2023

POM

1784 BRU18092413NP Eye Glo Relief Eye Drops 0.25% w/v

Zinc Sulphate 0.25% w/v Duopharma (M) Sdn Bhd, Malaysia

Bintang Ria Sdn Bhd 11 December 2018 till 10 December 2023

GSL

1785 BRU18092414NP SW Aqueous Cream Cetomacrogol 1000 2.75%w/wWhite Soft Paraffin 17.85%w/w

Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 11 December 2018 till 10 December 2023

GSL

1786 BRU18092415P Axcel Cefuroxime-125 for Oral Suspension (125mg/5ml)

Each 5ml contains:Cefuroxime Axetil equivalent to Cefuroxime 125mg

Kotra Pharma (M) Sdn. Bhd., NMalaysia

Medicorp Sdn Bhd 11 December 2018 till 10 December 2023

POM

1787 BRU18092416P (Applicant to be informed to remove label "to be dispensed on physician's prescription")

Horf Lozenges Chlorhexidine Hydrochloride 5mg; Benzocaine 2mg

Y.S.P Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 11 December 2018 till 10 December 2023

P

1788 BRU18092417NP Tiger Balm White Ointment Dementholised Mint Oil 16.0% w/w; Cajuput Oil 13.0% w/w; Camphor 11.0% w/w; Levomenthol (Menthol) BP 8.0% w/w; Clove Oil 1.5% w/w

Haw Par Healthcare Ltd, Singapore

Hamitan Marketing 11 December 2018 till 10 December 2023

GSL

1789 BRU18092418P Prolia Solution for Injection 60mg/mL (Prefilled Syringe)

Denosumab 60mg/mL Amgen Manufacturing Limited, United States

MediPharm Sdn Bhd 11 December 2018 till 10 December 2023

POM

BDMCA/RMP/1220 Page 131 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1790 BRU18102419PS1 & BRU18102419PS2

Zient® 10mg Tablet Ezetimibe 10mg 1. MSD Internaitonal GmbH (Singapore Branch), Singapore 2. MSD International GmbH (Puerto Rico Branch) LLC, Puerto Rico

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1791 BRU18102420P Simulect Lyophilisate for Injection 20mg per vial

Basiliximab 20mg Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1792 BRU18102421NP SW Calcium Lactate Tablet 300mg

Calcium Lactate 300mg Sunward Pharmaceutical Sdn Bhd, Malaysia

G&H Trading Company 11 December 2018 till 10 December 2023

GSL

1793 BRU18102422P Sulpin F.C. Tablets 200mg Sulpiride 200mg Taiwan Biotech Co. Ltd., Taiwan, Republic of China

K-Seri Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1794 BRU18102423P Quetiapine Fumarate Tablets 25mg

Quetiapine 25mg (as Quetiapine Fumarate 28.78mg)

Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1795 BRU18102424P Quetiapine Fumarate Tablets 200mg

Quetiapine 200mg (as Quetiapine Fumarate 230.26mg)

Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1796 BRU18102425P Quetiapine Fumarate Tablets 100mg

Quetiapine 100mg (as Quetiapine Fumarate 115.13mg)

Jubilant Generics Limited, India Asterix United (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1797 BRU18102426NP Volulyte 6% Solution for Infusion

Active ingredient (per 1000 ml)Poly (O-2-hydroxylethyl) starch 60.0 gSodium acetate trihydrate 4.63 gSodium chloride 6.02 gPotassium chloride 0.30 gMagnesium chloride hexahydrate 0.30 g

Fresenius Kabi Deutchland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1798 BRU18102427P Hydrogen Peroxide Solution 6% w/v

Hydrogen Peroxide 6% w/v Royce Pharma Manufacturing Sdn Bhd, Malaysia

SWL Biomed Sales & Services 11 December 2018 till 10 December 2023

GSL

1799 BRU18102428P Axcel Prednisolone-5mg EC Tablets

Prednisolone 5mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 11 December 2018 till 10 December 2023

POM

1800 BRU18102433P Udoxan Injection (1 ml amp)

Oxytocin (synthetic) 10 I.U. /ml Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1801 BRU18102434P Lignopad®medicated plaster 5%w/w

Lidocaine 5% w/w Teikoku Seiyaku Co Ltd, Japan Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1802 BRU18102435P CEFTREX INJECTION 1G IV CEFTRIAXONE

Ceftriaxone sodium equivalent to Ceftriaxone 1G

Biolab Co Ltd, Thailand Hongkiat Trading & Company 11 December 2018 till 10 December 2023

POM

1803 BRU18102436P Doxymycin-100 Capsules Doxycycline Hyclate BP equivalent to Doxycycline 100mg

Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 11 December 2018 till 10 December 2023

POM

1804 BRU18102437NP Optrex Multi Action Eye Wash Hamamelis Water (Witch Hazel) 13.0% v/v

Reckitt Beckinser Healthcare International Ltd, UK

Syarikat Aliaa Sdn Bhd 11 December 2018 till 10 December 2023

GSL

1805 BRU18102438NP Optrex Rehydrating Eye Drops Sodium Hyaluronate 0.165%w/w Reckitt Beckinser Healthcare International Ltd, UK

Syarikat Aliaa Sdn Bhd 11 December 2018 till 10 December 2023

GSL

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1806 BRU18102439P Candesartan Sandoz tablet 8mg

Candesartan cilexetil 8mg Lek Pharmaceuticals d.d., Slovenia

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1807 BRU18102440P Keytruda 25mg/mL Pembrolizumab 25mg/mL MSD Ireland (Carlow), Ireland Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1808 BRU18112441NP African Sea Coconut Brand Cough MIxture

Tolutanus Syrup BP 4.48% v/v; Tincture of Ipecacuanha BP 1953 2.24% v/v; Solution for Making Squill Elixir BP 1980 2.24% v/v; Liquorice Liquid Extract BP 2.24% v/v

Luen Fook Medicine (M) Sdn Bhd, Malaysia

Yuh Hua Trading Company 11 December 2018 till 10 December 2023

GSL

1809 BRU18112442P FRESOFOL 2% MCT/LCT EMULSION FOR INJECTION OR INFUSION

Propofol 20mg/ml Fresenius Kabi Austria GMBH (Plant Graz), Austria

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1810 BRU18112443P FRESOFOL 1% MCT/LCT EMULSION FOR INJECTION OR INFUSION

Propofol 10mg/ml Fresenius Kabi Austria GMBH (Plant Graz), Austria

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1811 BRU18112444NP SURGICAL SPIRIT Methylated spirit 98.8% v/v Sanchuan Medical Sdn BHd, Malaysia

SWL Biomed Sales & Services 11 December 2018 till 10 December 2023

GSL

1812 BRU18112445P ANDROZ 100 TABLET 100mg Sildenafil (as Sildenafil citrate 140.485mg)

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1813 BRU18112446P ANDROZ 50 TABLET 50mg Sildenafil (as Sildenafil citrate 70.243mg)

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1814 BRU18112447P VERAPIME POWDER FOR SOLUTION FOR INJECTION 1G/VIAL

Cefepime Hydrochloride Monohydrate equivalent to Cefepime 1g

DEMO S.A. Pharmaceutical Industry, Greece

Medicorp Sdn Bhd 11 December 2018 till 10 December 2023

POM

1815 BRU18112450PS1; BRU18112450PS2

REBIF SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE 22MCG/0.5ML

Each pre-filled cartridge contains 66 micrograms (18 MIU*) of interferon beta-1 a** in 1.5mL solution, corresponding to 44 micrograms/rnl.* Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house IFN beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531).** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.

1) Merck Serono S.p.A., Italy2) Merck Serono S.A., Switzerland

G&H Trading Company 11 December 2018 till 10 December 2023

POM

BDMCA/RMP/1220 Page 133 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1816 BRU18112451PS1; BRU18112451PS2

REBIF SOLUTION FOR INJECTION IN PRE-FILLED CARTRIDGE 44 MCG/0.5ML

Each pre-filled cartridge contains 132 micrograms (36 MIU*) of interferon beta-1 a** in 1.5mL solution, corresponding to 88 micrograms/rnl.* Million International Units, measured by cytopathic effect (CPE) bioassay against the in-house IFN beta-1a standard which is calibrated against the current international NIH standard (GB-23-902-531).** produced in Chinese hamster ovary Cells (CHO-K1) by recombinant DNA technology.

1) Merck Serono S.p.A., Italy2) Merck Serono S.A., Switzerland

G&H Trading Company 11 December 2018 till 10 December 2023

POM

1817 BRU18112452P Nelin 150mg/1.5mL Injection Netilmicin Sulfate USP Eq. to Netilmicin 150mg/1.5mL

Biolab Company Ltd, Thailand K-Seri Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1818 BRU18112453P Midazolam-Hameln 5mg/ml Injection, 3ml

Midazolam (as hydrochloride) 15mg/3ml

Siegfried Hameln GmbH, Germany

Medicorp Sdn Bhd 11 December 2018 till 10 December 2023

POM

1819 BRU18112454P APO-ATENIDONE TABLETS 100/25MG

Atenolol 100mg and Chlorthalidone 25mg

Apotex Inc, Canada Medicorp Sdn Bhd 11 December 2018 till 10 December 2023

POM

1820 BRU18112455P Torio Tablet Simvastatin 10mg Unison Laboratories Co. Ltd., Thailand

K-Seri Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1821 BRU18112456P Arvastatil 10mg Film Coated Tablets

Atorvastatin calcium Trihydrate eq. to Atorvastatin 10mg

One-Pharma Industrial Pharmaceutical Company S.A., Greece

Medicorp Sdn Bhd 11 December 2018 till 10 December 2023

POM

1822 BRU18112457P Arvastatil 20mg Film Coated Tablets

Atorvastatin calcium Trihydrate eq. to Atorvastatin 20mg

One-Pharma Industrial Pharmaceutical Company S.A., Greece

Medicorp Sdn Bhd 11 December 2018 till 10 December 2023

POM

1823 BRU18112458P Arvastatil 40mg Film Coated Tablets

Atorvastatin calcium Trihydrate eq. to Atorvastatin 40mg

One-Pharma Industrial Pharmaceutical Company S.A., Greece

Medicorp Sdn Bhd 11 December 2018 till 10 December 2023

POM

1824 BRU18112459P Ificipro 250mg Tablets Ciprofloxacin Hydrochloride USP eq. to Ciprofloxacin 250mg

Unique Pharmaceutical Laboratories (A Division of JB Chemicals & Pharmaceuticals Limited), India

K-Seri Pharma Sdn Bhd 11 December 2018 till 10 December 2023

POM

1825 BRU18112460P Humira 40mg/0.4ml Solution for Injection

Adalimumab 40mg/0.4ml Vetter Pharma-Fertigung, Germany [secondary packaging: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore]

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

BDMCA/RMP/1220 Page 134 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1826 BRU18112461P IMACH INJECTION 1ML Chlorpheniramine maleate 10mg/1ml SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 11 December 2018 till 10 December 2023

POM

1827 BRU18112462NP Silverderm cream Silver Sulfadiazine 1% w/w T.O. Chemicals (1979) Ltd, Thailand

Medicorp Sdn Bhd 11 December 2018 till 10 December 2023

P

1828 BRU18112463P Granisetron-AFT Solution for Injection 1mg/ml

Granisetron hydrochloride equivalent to Granisetron 1mg/ml

Qilu Pharmaceutical Co. Ltd., P.R. China

Medipharm Sdn Bhd 11 December 2018 till 10 December 2023

POM

1829 BRU18112464P Lenvima 4mg Hard Capsule Lenvatinib 4mg (equivalent to 4.90mg levatinib mesilate)

Patheon Inc., Canada Medipharm Sdn Bhd 11 December 2018 till 10 December 2023

POM

1830 BRU18112465P Lenvima 10mg Hard Capsule Lenvatinib 10mg (equivalent to 12.25mg levatinib mesilate

Patheon Inc., Canada Medipharm Sdn Bhd 11 December 2018 till 10 December 2023

POM

1831 BRU18112466P KISQALI 200MG FILM-COATED TABLET

Ribociclib succinate equivalent to 200mg ribociclib

Novartis Singapore Pharmaceutical Manufacturing Pte Ltd., Singapore

Zuellig Pharma (B) Sdn Bhd 11 December 2018 till 10 December 2023

POM

1832 BRU18112467P Zylovaa Tablet 50mg Losartan Potassium 50mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 11 December 2018 till 10 December 2023

POM

1833 BRU18122468P CLOXABIOTIC INJECTION 500MG

Cloxacillin sodium BP equivalent to cloxacillin 500mg

Karnataka Antibiotics & Pharmaceuticals Limited (A. Govt of India Enterprise), India

K-Seri Pharma Sdn. Bhd 04 March 2019 till 03 March 2024

POM

1834 BRU18122469P Losartan Potassium Tablet 50mg

Losartan Potassium 50mg Jubilant Generics Limited, INDIA. Asterix United (B) Sdn Bhd. 04 March 2019 till 03 March 2024

POM

1835 BRU18122470P Losartan Potassium Tablet 100mg

Losartan Potassium 100mg Jubilant Generics Limited, INDIA. Asterix United (B) Sdn Bhd. 04 March 2019 till 03 March 2024

POM

1836 BRU18122471P Injecsol LIG2 (Lignocaine Hydrochloride Injection 2% w/v)

Lignocaine Hydrochloride 20mg /mL Ain Medicare Sdn. Bhd, Malaysia.

Syarikat Pakatan Indah 04 March 2019 till 03 March 2024

POM

1837 BRU18122472NP Injecsol S20 (Sodium Chloride 20% w/v Injection BP)

Each 10ml contains Sodium chloride 2g (Na+ 34.2mmol, CL- 34.2mmol)

Ain Medicare Sdn. Bhd., Malaysia.

Syarikat Pakatan Indah 04 March 2019 till 03 March 2024

POM

1838 BRU18122473P Dyna Ferrous Fumarate Tablet Ferrous Fumarate 200mg Dynapharm (M) Sdn Bhd (65683-V), Pulau Pinang, Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

GSL

1839 BRU18122474P OXYNORM 5MG CAPSULES Each capsule contains:4.5mg oxycodone as 5mg oxycodone hydrochloride.

Bard Pharmaceuticals Limited, United Kingdom.

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March 2024

POM

1840 BRU18122475P OXYNORM 10MG CAPSULES Each capsule contains:9mg oxycodone as 10mg oxycodone hydrochloride.

Bard Pharmaceuticals Limited, United Kingdom.

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March 2024

POM

BDMCA/RMP/1220 Page 135 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1841 BRU18122480PS1 & BRU18122480PS2

MUCODIN TABLET 375MG Carbocysteine 375mg 1. Sunward Pharmaceutical Sdn Bhd, Malaysia;2. Sunward Pharmaceutical Pte Ltd, Singapore, Note: Both sites conducts their batch releases and share the same package insert and separate label artwork

G & H Trading Company 04 March 2019 till 03 March 2024

P

1842 BRU18122481P Kary Uni® Ophthalmic Suspension (Pirenoxine 0.005%)

Pirenoxine 0.05mg/ mL Santen Pharmaceutical Co., Japan

MediPharm Sdn Bhd 04 March 2019 till 03 March 2024

POM

1843 BRU18122482NP Belcid Suspension Each 15ml contains:Aluminum Hydroxide Gel USP eq. to Aluminium Hydroxide 918mgMagnesium Hydroxide USP 300mgSimethicone USP 60mg

Biolab Company Ltd., Thailand. Hongkiat Trading & Company 04 March 2019 till 03 March 2024

GSL

1844 BRU18122483NP Eye Glo Moist Eye Drops Hydroxypropyl methylcellulose 0.3% w/v

Duopharma (M) Sdn Bhd, Malaysia.

Bintang Ria Sdn Bhd 04 March 2019 till 03 March 2024

GSL

1845 BRU18122484NP Mifulin lotion Salicylic acid 12% Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 04 March 2019 till 03 March 2024

GSL

1846 BRU18122485P Ketazon shampoo Ketoconazole 2g/100ml Siam Bheasach Co Ltd, Thailand K-Seri Pharma Sdn. Bhd. 04 March 2019 till 03 March 2024

GSL

1847 BRU18122486P DURATOCIN® 100mcg/ml Injection

Carbetocin 100mcg/ml Ferring GmbH, Germany

Repacker: Zuellig Pharma Specialty Solutions Group Pte. Ltd., Singapore

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March 2024

POM

1848 BRU18122487NP Alucid Suspension Each 10ml contains:Aluminium Hydroxide 800mg, Magnesium Hydroxide 800mg, Simethicone 60mg

Upha Pharmaceutical Manufacturing (M) Sdn Bhd, Malaysia

Bintang Ria Sdn Bhd 04 March 2019 till 03 March 2024

GSL

1849 BRU19012488P BENZAPEN 2.4MIU INJECTION Sterile Penicillin G Benzathine 1.8G (2.4 MU)

Karnataka Antibiotics & Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March 2024

POM

BDMCA/RMP/1220 Page 136 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1850 BRU19012489NP VITBION FORTE TABLET Vitamin B1 HCl (Thiamine HCl) 100mgVitamin B6 HCL (Pyridoxine HCl) 200mgVitamin B12 HCL (Cyanocobalamin) 200mcg

Dynapharm (M) Sdn Bhd, Malaysia.

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

GSL

1851 BRU19012490NP MENTHOLATUM DEEP HEATING PLASTER

L-Menthol 4.26% Teh Seng Pharmaceutical Mfg. Co., Ltd., Taiwan, R.O.C

Hamitan Marketing 04 March 2019 till 03 March 2024

GSL

1852 BRU19012491P FENTANYL-HAMELN 50 MCG/ML INJECTION

Fentanyl citrate (0.157mg) eq. to fentanyl 0.1mg/2ml

Siegfried Hameln GmbH Germany

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

POM

1853 BRU19012492P AXINOL TABLET 20MG Trimetazidine dihydrochloride 20mg T.O Chemicals (1970) Co. Ltd., Thailand.

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

POM

1854 BRU19012493P HCQS (HYDROXYCHLOROQUINE TABLETS BP 200MG)

Hydroxychloroquine Sulfate BP 200mg Ipca Laboratories Limited, India. K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March 2024

POM

1855 BRU19012494P VAXCEL CEFEPIME 1G INJECTION

Cefepime Hydrochloride buffered with L-Arginine equivalent to Cefepime 1g

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

POM

1856 BRU19012495NP POVIDONE IODINE, THREE LEGS BRAND

Povidone Iodine 10% w/v Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 04 March 2019 till 03 March 2024

GSL

1857 BRU19012496P ALTRATM TABLET 10MG Montelukast 10mg (as montelukast sodium 10.66mg)

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Co. 04 March 2019 till 03 March 2024

POM

1858 BRU19012497P AXCEL DIPHENHYDRAMINE PAEDIATRIC SYRUP

Diphenhydramine hydrochloride 7mg / 5mlAmmonium chloride 67.5mg / 5ml

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

POM

1859 BRU19012498NP VISIPAQUE 320 MG I/ML, SOLUTION FOR INJECTION

Iodixanol 652 mg/ml eq to 320 mg I/ml GE Healthcare (Shanghai) Co., Ltd, China

Medipharm Sdn Bhd 04 March 2019 till 03 March 2024

POM

1860 BRU19012499PS1 & BRU19012499PS2

ALBUNORM 20%, 200G/L, SOLUTION FOR INFUSION

200g/l of total protein of which at least 96% is human albumin

i) Octapharma Pharmazeutika Produktionsges.m.b.H, Austriaii) Octapharma Produktionsgesellschaft Deutschland mbH, Germany

G&H Trading Company 04 March 2019 till 03 March 2024

POM

BDMCA/RMP/1220 Page 137 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1861 BRU19012500PS1 & BRU19012500PS2

ALBUNORM 5%, 50G/L, SOLUTION FOR INFUSION

50g/l of total protein of which at least 96% is human albumin

i) Octapharma Pharmazeutika Produktionsges.m.b.H, Austriaii) Octapharma Produktionsgesellschaft Deutschland mbH, Germany

G&H Trading Company 04 March 2019 till 03 March 2024

POM

1862 BRU19012501PS1 & BRU19012501PS2

ALBUNORM 25%, 250G/L, SOLUTION FOR INFUSION

250g/l of total protein of which at least 96% is human albumin

i) Octapharma Pharmazeutika Produktionsges.m.b.H, Austriaii) Octapharma S.A.S., Lingolsheim, France.

G&H Trading Company 04 March 2019 till 03 March 2024

POM

1863 BRU19012502P VAXIGRIP TETRA SUSPENSION FOR INJECTION IN PREFILLED SYRINGE

A/Brisbane/02/2018 (H1N1)pdm09-like strain (A/Brisbane/02/2018 IVR-190) 15 mcg HA**A/South Australia/34/2019 (H3N2) - like strain (A/South Australia/34/2019, IVR-197) 15 mcg HA**B/Washington/02/2019 - like strain (B/Washington/02/2019, wild type)15 mcg HA**B/Phuket/3073/2013 – like strain (B/Phuket/3073/2013, wild type)15 mcg HA**

For one 0.5ml dose

*propagated in fertilised hen’s eggs from healthy chicken flocks**haemagglutinin

Sanofi Pasteur, Val De Reuil, France

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March 2024

POM

1864 BRU19012503NP REGIOCIT SOLUTION FOR HAEMOFILTRATION

Sodium chloride 5.03 g/LSodium citrate 5.29 g/L

Bieffe Medital S.p.A., Italy Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

POM

1865 BRU19012504P PYRONIUM INJECTION 200MCG/ML

Glycopyrrolate 200mcg/ml SM Pharmaceuticals Sdn Bhd, Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

POM

1866 BRU19012505P HERCEPTIN SOLUTION FOR INJECTION 600MG/5ML

Trastuzumab 600mg/5ml F.Hoffmann-La Roche Ltd., Kaiseraugst, Switzerland

Medipharm Sdn Bhd 04 March 2019 till 03 March 2024

POM

BDMCA/RMP/1220 Page 138 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1867 BRU19012506P EZETIMIBE SANDOZ TABLET 10MG

Ezetimibe 10mg Lek Pharmaceuticals, Ljubljana, Slovenia; Lek Pharmaceuticals d.d. Lendava, Slovenia

Zuellig Pharma (B) Sdn. Bhd 04 March 2019 till 03 March 2024

POM

1868 BRU19022507P APO-FLUCONAZOLE 100MG TABLETS

FLUCONAZOLE 100MG Apotex Inc., Canada Medipharm Sdn Bhd 04 March 2019 till 03 March 2024

POM

1869 BRU19022508NP NUTRILITE IRON FOLIC TABLET IRON 10MG FOLATE (FOLIC ACID) 0.133MG

Access Business Group LLC, USA Amway (B) Sdn Bhd 04 March 2019 till 03 March 2024

GSL

1870 BRU19022509P CEFATUM INJECTION 1G CEFTAZIDIME 1GM Duopharma (M) Sdn Bhd, Malaysia

Hongkiat Trading & Company 04 March 2019 till 03 March 2024

POM

1871 BRU19022510NP Hovid-Folic Acid Tablets 5mg FOLIC ACID 5MG HOVID Bhd., Malaysia G&H Trading Company 04 March 2019 till 03 March 2024

GSL

1872 BRU19022511P Clopine 100MG Tablet Clozapine 100mg Douglas Manufacturing Ltd., New Zealand

K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March 2024

POM

1873 BRU19022512P Vaxcel Omeprazole 40mg Injection

Omeprazole Sodium equivalent to Omeprazole 40mg

Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

POM

1874 BRU19022513NP Medon 500 capsule Paracetamol 500mg Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 04 March 2019 till 03 March 2024

P

1875 BRU19022514P Bufencon Injection Betamethasone (as dipropionate) 5mg & Betamethasone (as phosphate disodium) 2mg

Yung Shin Pharmaceutical Ind. Co. Ltd., Taiwan, Republic of China

Asterix (B) Sdn Bhd 04 March 2019 till 03 March 2024

POM

1876 BRU19022515NP PARACETAMOL-AFT SOLUTION FOR INFUSION 10MG/ML

Paracetamol 10mg/ml S.M. Farmaceutici SRL, Italy MediPharm Sdn Bhd 04 March 2019 till 03 March 2024

POM

1877 BRU19022516P Domi Injection 15mg (3ml Amp)

Midazolam HCl equivalent to Midazolam 15mg/3ml

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 04 March 2019 till 03 March 2024

POM

1878 BRU19022517P Baraclude® 0.5mg Tablets Entecavir 0.5mg Bristol-Myers Squibb Company, USA

Medipharm Sdn Bhd 04 March 2019 till 03 March 2024

POM

1879 BRU19022518NP Tricera Cleanser 1.6% w/w Pine Tar 1.6% HOE Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 04 March 2019 till 03 March 2024

GSL

1880 BRU19022519P Chloroquine Tablets 250mg Chloroquine Phosphate BP 250mg equivalent to Chloroquine Base 150mg

Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 04 March 2019 till 03 March 2024

POM

1881 BRU19022520P KENO ORAL PASTE Triamcinolone acetonide 1 mg/g T.O. CHEMICALS (1979) LTD., Thailand

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

P

1882 BRU19022521P ATRACURIUM-HAMELN 10MG/ML INJECTION, 2.5ML

Atracurium besilate 25mg in 2.5ml (10mg/ml)

Hameln Pharmaceuticals GmbH, Germany

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

POM

1883 BRU19022522NP Kidz PCM 250 Suspension (Strawberry)

Paracetamol 250mg/5ml Winwa Medical Sdn Bhd, Pulau Pinang, Malaysia

Yuh Hua Trading Company 04 March 2019 till 03 March 2024

GSL

BDMCA/RMP/1220 Page 139 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1884 BRU19022523NP Povil Antacid Tablet Dried Aluminium Hydroxide 250 mg, Magnesium Hydroxide 250 mg, Simethicone 50 mg

Winwa Medical Sdn Bhd, Pulau Pinang, Malaysia

Medicorp Sdn Bhd 04 March 2019 till 03 March 2024

GSL

1885 BRU19022524P Inlyta® 1mg Film-Coated Tablet

Axitinib 1mg Pfizer manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn. Bhd 04 March 2019 till 03 March 2024

POM

1886 BRU19022525P Inlyta® 5mg Film-Coated Tablet

Axitinib 5mg Pfizer manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March 2024

POM

1887 BRU19022526P Taflotan Ophthalmic Solution 0.0015%

Tafluprost 0.0015% Santen Pharmaceutical Co., Ltd., Shiga Plant, Japan

MediPharm Sdn Bhd 04 March 2019 till 03 March 2024

POM

1888 BRU19022527NP Paracil suspension 250mg/5ml Paracetamol 250mg/5ml SM Pharmaceuticals Sdn Bhd, Malaysia

G& H Trading Company 04 March 2019 till 03 March 2024

GSL

1889 BRU19022528P DTI for Injection 200mg Dacarbazine 200mg Korea United Pharm, Inc., Republic of Korea

Kingsley Medical Supplies Sdn Bhd

04 March 2019 till 03 March 2024

POM

1890 BRU19022529P Sildegra 100mgTablets Sildenafil Citrate 140.4mg equivalent to Sildenafil 100mg

Sandoz Private Limited, India Zuellig Pharma (B) Sdn Bhd 04 March 2019 till 03 March 2024

POM

1891 BRU19032530P Imexa powder for oral suspension 200mg/5ml

Azithromycin 200mg/5ml Xepa-Soul Pattinson (Malaysia) Sdn Bhd

Hongkiat Trading & Company 16 July 2019 till 15 July 2024

POM

1892 BRU19032531P Dysolvon Syrup (Raspberry) Bromhexine hydrochloride 4mg/5ml Dynapharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

P

1893 BRU19032532NP Paracil Tablet 500mg Paracetamol 500mg SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 16 July 2019 till 15 July 2024

GSL & P

1894 BRU19032533NP Cap Kaki Tiga Ai Kan Shan Fever Powder

Paracetamol 500mg / sachet Syarikat Wen Ken Drug Sdn Bhd, Malaysia

Syarikat Rajamas Bersama 16 July 2019 till 15 July 2024

GSL

1895 BRU19032534NP Dyna Calamine Lotion Calamine Powder 150mg/ml (15% w/v) Dynapharm (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

GSL

1896 BRU19032535P Gazyva Concentrate for Solution for Infusion

Obinutuzumab 1000mg/40mL Roche Diagnostics GmbH, Germany

MediPharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1897 BRU19032536P Pyrimine Tablet 60mg Pyridostigmine Bromide 60mg Sriprasit Pharma Co., Ltd., Thailand

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

1898 BRU19032537P Ceftriaxone-AFT Powder for Injection 1g

Ceftriaxone sodium 1.079g (equivalent to ceftriaxone 1g)

Qilu Pharmaceutical Co., Ltd., China

MediPharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1899 BRU19032538NP U-Lite Effervescent Granules Each 4.1gm contains:Sodium Bicarbonate 1.76gCitric Acid 0.72gSodium Citrate 0.63gTartaric Acid 0.89g

Winwa Medical Sdn Bhd, Pulau Pinang, Malaysia

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

GSL

1900 BRU19032539P Coldmax Suspension Each 5ml contains:Paracetamol 250mgPseudoephedrine HCl 15mgChlorpheniramine Maleate 1mg

Winwa Medical Sdn Bhd, Pulau Pinang, Malaysia

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

P

BDMCA/RMP/1220 Page 140 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1901 BRU19032540NP Kidz PCM 250 Suspension (Orange)

Paracetamol 250mg/5ml Winwa Medical Sdn Bhd, Pulau Pinang, Malaysia

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

GSL

1902 BRU19032541NP UNI-MA ENEMA SOLUTION Each 118ml (delivered dose) contains:: Sodium bisphosphonate 19g; Sodium phosphate 7g

Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

P

1903 BRU19032542P Ciprocep Tablet 250mg Ciprofloxacin Hydrochloride 291.5mg equivalent to Ciprofloxacin 250mg

T.O. Pharma Co. Ltd., Thailand Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

1904 BRU19032543P Ferriprox 1000mg Film Coated Tablet

Deferiprone 1000mg Apotex Inc., Canada Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

1905 BRU19032544P Octocaine 100 Each ml contains:i) Lidocaine Hydrochloride 20mgii) Epinephrine bitartrate 0.018mg

Novocol Pharmaceutical of Canada Inc., Canada

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

1906 BRU19032545NP ANIOSGEL 85 NPC Ethanol 70%(700mg/g i.e 755ml/L

Laboratoires Anios, France K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

GSL

1907 BRU19032546NP ANTHPHLAMINE S LOTION Methylsalicylate 20% w/w L-Menthol 6% w/w

Yuhan Corporation, South Korea Kingsley Medical Supplies Sdn Bhd

16 July 2019 till 15 July 2024

GSL

1908 BRU19032547NP Woods Peppermint Cough Syrup for Children

Guaiphenesin 50mg/5ml IDS Manufacturing Sdn Bhd, Malaysia

M.S. Makmur Trading Company

16 July 2019 till 15 July 2024

GSL

1909 BRU19032548NP Xubil Oral Solution Each 5ml contains:Monobasic sodium phosphate 2.4 g;Dibasic sodium phosphate 0.9 g

Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1910 BRU19042549P Oxytocin-Richter Solution for Injection 10 IU/1ml

Oxytocin 10 I.U./1ml Gedeon Richter Plc., Hungary K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1911 BRU19042550P Vivic Tablet 100mg Sildenafil 100mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 16 July 2019 till 15 July 2024

POM

1912 BRU19042551P Requip PD 24 hour Prolonged Release Tablet 4mg

Ropinirole hydrochloride (eq to 4mg ropinirole free base)

Glaxo Wellcome S.A, Spain Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1913 BRU19042552NP Axcel Folic Acid 5mg Folic Acid 5mg Kotra Pharma (M) Sdn Bhd, Malaysia

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

GSL

1914 BRU19042553P Maxigesic Tablet 500mg/150mg

Paracetamol 500mg Ibuprofen 150mg

Sigma Laboratories Ltd, India Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

P

1915 BRU19042554P Arnetin 50mg/2ml Solution for Injection/Infusion

Ranitidine (as ranitidine hydrochloride) 50mg/2ml

Medochemie Ltd., Cyprus Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

BDMCA/RMP/1220 Page 141 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1916 BRU19042555P Clavomax 625mg Tablet Each tablet contains:573.96mg Amoxicillin Trihydrate (eq. to Amoxicillin 500mg) and 148.91mg Potassium Clavulanate (eq. to Clavulanic acid 125mg)

China Chemical & Pharmaceutical Co. Ltd, Taiwan

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

1917 BRU19042556P Chlorop Eye Ointment 1% Chloramphenicol 10mg/g (1%) SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 16 July 2019 till 15 July 2024

POM

1918 BRU19042557P Akoset Injection 20mg/2ml Frusemide 20mg/2ml Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1919 BRU19042558P Lipiodol Ultra Fluid 480mg l/ml, Solution for Injection

Ethyl esters of iodized fatty acids of poppy seed oil corresponds to iodine 480mg/ml

Delpharm Tours, France Manning Jaya Trading (B) Sdn Bhd

16 July 2019 till 15 July 2024

POM

1920 BRU19042559NP Povil Antacid Mixture (Peppermint)

Each 10ml contains:Aluminium Hydroxide 400 mgMagnesium Hydroxide 400 mg

Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 16 July 2019 till 15 July 2024

GSL

1921 BRU19042560P Betacort Cream 0.1% w/w Each gram cream contains: Betamethasone Valerate equivalent to 1mg Betamethasone (0.1%w/w).

SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 16 July 2019 till 15 July 2024

POM

1922 BRU19042561P Cravit Ophthalmic Solution 0.5%

Levofloxacin hydrate 5mg/mL Santen Pharmaceutical Asia Pte. Ltd., Singapore

Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1923 BRU19042563P Apo-Amilzide Tablet Each tablet contains: Hydrochlorothiazide 50mg, Amiloride Hydrochloride 5mg

Apotex Inc., Canada Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1924 BRU19042564P Tenof-EM Tablet Emtricitabine 200mg, Tenofovir Disproxil Fumarate 300mg

Hetero Labs Limited, India K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1925 BRU19042565P Freederm Lotion Terbinafine HCl 1% w/v Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 16 July 2019 till 15 July 2024

GSL

1926 BRU19042566NP Yellow Lotion 0.4% Acriflavine Hydrochloride 0.4% w/v Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 16 July 2019 till 15 July 2024

GSL

1927 BRU19042569P Lamitor 50mg Tablet Lamotrigine 50mg Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1928 BRU19042570P Onsia Tablet 8mg Ondansetron hydrochloride dihydrate (9.977mg) eq to ondansetron 8mg

Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1929 BRU19042571P Tivicay™ 50mg Film-Coated Tablets

Dolutegravir 50mg (as dolutegravir sodium)

Glaxo Operations UK Ltd, United Kingdom

Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1930 BRU19042572P Minirin® Nasal Spray 0.1mg/ml

Desmopressin acetate 0.1mg/ml eq. to 89mcg desmopressin (10mcg/dose)

Ferring GmBH, Germany Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1931 BRU19042573P URSA 250MG CAPSULE Ursodeoxycholic acid 250mg Daewoong Pharmaceutical Co. Ltd., Republic of Korea

Kingsley Medical Supplies Sdn Bhd

16 July 2019 till 15 July 2024

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1932 BRU19042574P Spiriva Respimat 2.5mcg Solution for Inhalation

Per puff: 2.5mcg Tiotropium eq. to 3.124mcg tiotropium bromide monohydrate

Boehringer Ingelheim Pharma GmBH & Co. KG, Germany

Hongkiat Trading & Company 16 July 2019 till 15 July 2024

POM

1933 BRU19042575P Lavudin Standard F.C. Tablet 100mg

Lamivudine 100mg Standard Chem. & Pharm. Co. Ltd, Taiwan

Kingsley Medical Supplies Sdn Bhd

16 July 2019 till 15 July 2024

POM

1934 BRU19042576P Faslodex Solution for Injection 250mg/5ml

Fulvestrant 250mg/5ml Vetter Pharma-Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1935 BRU19042577NP Multibic potassium-Free Solution for Haemofiltration (Solution, sterile)

1000 ml of the ready-to-use solution contain:Sodium chloride 6.136 g;Sodium hydrogen carbonate 2.940 gCalcium chloride dihydrate 0.2205 gMagnesium chloride hexahydrate 0.1017 gGlucose monohydrate 1.100 g (anhydrous glucose 1.000 g)

Fresenius Medical Care Deutschland GmbH, Germany

Medix Supplier 16 July 2019 till 15 July 2024

GSL

1936 BRU19052578P Pregeb Capsules 75mg Pregabalin 75mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1937 BRU19052579NP Omnipaque 300mg l/mL, Solution for Injection/Infusion

Iohexol (INN) 300 mg I/ml (647 mg equivalent to 300mg I)

GE Healthcare (Shanghai) Co., China

Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1938 BRU19052580NP Omnipaque 350mg l/mL, Solution for Injection/Infusion

Iohexol (INN) 350 mg I/ml (755 mg equivalent to 350mg I)

GE Healthcare (Shanghai) Co., China

Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1939 BRU19052581P Streptin Injection 1g Streptomycin Sulphate equivalent to Streptomycin 1g

SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 16 July 2019 till 15 July 2024

POM

1940 BRU19052582P Aricept Evess 5mg Orodispersible Tablet

Donepezil hydrochloride 5mg Bushu Pharmaceuticals Ltd. 950, Japan

Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1941 BRU19052583P Aricept Evess 10mg Orodispersible Tablet

Donepezil hydrochloride 10mg Bushu Pharmaceuticals Ltd. 950, Japan

Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1942 BRU19052584P Yucomy Shampoo 2% w/w Ketoconazole 20mg/g (2% w/w) Y.S.P Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 16 July 2019 till 15 July 2024

GSL

1943 BRU19052585P Mapin 0.4mg/ml Injection Naloxone Hydrochloride 0.4mg/ml Duopharma (M) Sdn Bhd., Malaysia

K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1944 BRU19052586P Apo-Warfarin 1mg Tablet Warfarin Sodium 1mg Apotex Inc., Canada Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1945 BRU19052587PS1 & BRU19052587PS2

Medovir 400mg Tablet Aciclovir 400mg Medochemie Ltd- Central Factory, Limassol, Cyprus (S1); Medochemie (Far East) Ltd. – Oral Factory, Bing Duong Province, Vietnam (S2)

Hongkiat Trading & Company 16 July 2019 till 15 July 2024

POM

BDMCA/RMP/1220 Page 143 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1946 BRU19052588P Bisloc 2.5 Bisoprolol Fumarate 2.5mg Unison Laboratories Co., Thailand

K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1947 BRU19052589P Derzid Cream Each 100g contains betamethasone valerate equivalent to betamethasone 0.1g (0.1% w/w)

Unison Laboratories Co. Ltd., Thailand

K-Seri Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1948 BRU19052590P Pentasa® Prolonged Release Tablet 500mg

Mesalazine 500mg Ferring International Center SA, Switzerland

Zuellig Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1949 BRU19052591P Apo-montelukast Chewable Tablets 4mg USP

Montelukast (as sodium) 5mg Apotex Research Private Ltd, India

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

1950 BRU19052592P Apo-montelukast Chewable Tablets 5mg USP

Montelukast (as sodium) 5mg Apotex Research Private Ltd, India

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

1951 BRU19052593P Apo-montelukast Tablets 10mg

Montelukast (as sodium) 10mg Apotex Research Private Ltd, India

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

1952 BRU19052594P SW Bromhexine Elixir Bromhexine Hydrochloride 4mg/5ml Sunward Pharmaceutical Sdn Bhd, Malaysia

G&H Trading Company 16 July 2019 till 15 July 2024

P

1953 BRU19052595P Allersin Syrup 4mg/5ml Chlorpheniramine maleate 4mg/5ml Sunward Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 16 July 2019 till 15 July 2024

P

1954 BRU19052596P Quetiapine Sandoz 100mg Tablets

Quetiapine (as fumarate) 100mg Sandoz Ilac Sanayi ve Ticaret A.S, Turkey

Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1955 BRU19052597P Cifloxin Infusion (2mg/ml) Ciprofloxacin 2mg/ml Siam Bheasach Co. Ltd., Thailand K-Seri Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1956 BRU19052598NP Tiger Balm Soft i) Cajuput Oil 13.0% w/wii) Menthol 12.0% w/wiii) Camphor 10.0% w/wiv) Clove Oil 1.5% w/w

Tiger Balm (M) Sdn Bhd., Malaysia

Hamitan Marketing 16 July 2019 till 15 July 2024

GSL

1957 BRU19052599P Vizomet Cream 0.1% w/w Mometasone Furoate 0.1% w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 16 July 2019 till 15 July 2024

POM

1958 BRU19052600P Vizomet Ointment 0.1% w/w Mometasone Furoate 0.1% w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 16 July 2019 till 15 July 2024

POM

1959 BRU19052601P Eperon Film Coated Tablets 2mg

Risperidone 2mg Medochemie Ltd (Central Factory), Cyprus

Hongkiat Trading & Company 16 July 2019 till 15 July 2024

POM

1960 BRU19052602P Quetiapine Sandoz 25mg Tablets

Quetiapine (as fumarate) 25mg Sandoz Ilac Sanayi ve Ticaret A.S, Turkey

Zuellig Pharma (B) Sdn Bhd 2602P

16 July 2019 till 15 July 2024

POM

1961 BRU19072603P Vectibix Concentrate for Solution for Infusion 100mg/vial

Each vial contains 100mg of panitumumab in 5ml

Amgen Manufacturing Limited, United States

Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1962 BRU19072604P Simponi I.V. Concentrate for Solution for Infusion 12.5mg/1ml

Golimumab 12.5mg/ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1963 BRU19072607NP Thelban Suspension Albendazole 100mg/5ml Biolab Company Ltd., Thailand Hongkiat Trading & Company 16 July 2019 till 15 July 2024

GSL

BDMCA/RMP/1220 Page 144 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1964 BRU19072608NP Xenetix 300 Solution for Injection

Iobitridol 65.81g/100ml (corresponding to 30g iodine/100ml

Guerbet, France Manning Jaya Trading (B) Sdn Bhd

16 July 2019 till 15 July 2024

POM

1965 BRU19072609NP Xenetix 350 Solution for Injection

Iobitridol 76.78g/100ml (corresponding to 35g iodine/100ml)

Guerbet, France Manning Jaya Trading (B) Sdn Bhd

16 July 2019 till 15 July 2024

POM

1966 BRU19072610P Fycompa 2mg Film-Coated Tablets

Perampanel 2mg Eisai Manufacturing Limited. United Kingdom

Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1967 BRU19072611P Fycompa 4mg Film-Coated Tablets

Perampanel 4mg Eisai Manufacturing Limited. United Kingdom

Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1968 BRU19072612P Fycompa 8mg Film-Coated Tablets

Perampanel 8mg Eisai Manufacturing Limited. United Kingdom

Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1969 BRU19072613NP Renal-Sol B1 Each litre of concentrate contains:Sodium Chloride (BP) 30.58g;Sodium Bicarbonate (BP) 66.00g;Highly Purified Water (B) 1000.0ml

Renal Laboratories Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

GSL

1970 BRU19072614P Tacarline Injection 1mg/ml Each ampoule contains:Adrenaline Acid Tartate 1.8mg/ml

Duopharma (M) Sdn. Bhd., Malaysia

K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1971 BRU19072615P Ranexa Prolonged-release Tablet 375mg

Ranolazine 375mg Menarini, Germany Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1972 BRU19072616P Ranexa Prolonged-release Tablet 500mg

Ranolazine 500 mg Menarini, Germany Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1973 BRU19072617P Ranexa Prolonged-release Tablet 750mg

Ranolazine 750 mg Menarini, Germany Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1974 BRU19072618P SotaHexal 80mg Tablet Sotalol Hydrochloride 80mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

1975 BRU19072619P Zafibral 200mg Tablets Film Coated

Bezafibrate 200mg Medochemie Ltd, Cyprus G & H Trading Company 16 July 2019 till 15 July 2024

POM

1976 BRU19072620P Apo-Azathioprine 50mg tablets

Azathioprine 50mg RPG Lifesciences Limited, India Medicorp Sdn. Bhd 16 July 2019 till 15 July 2024

POM

1977 BRU19072621P Pergoveris Powder and Solvent for Solution for Injection

One vial contains 150IU (equivalent to 11 micrograms) of follitropin alfa (r-hFSH) and 75IU (equivalent to 3 micrograms) of lutropin alfa (r-hLH).

Merck Serono S.A. (MS-Aubonne), Switzerland

G & H Trading Company 16 July 2019 till 15 July 2024

POM

BDMCA/RMP/1220 Page 145 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1978 BRU19072622P Trustiva Tablet i) Efavirenz 600mgii) Emtricitabine 200mgiii) Tenofovir Disoproxil Fumarate 300mg eq. to Tenofovir Disoproxil 245mg

Hetero Labs Limited, India K-Seri Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1979 BRU19072623P Miloz Injection 15mg/3ml Midazolam 5mg/ml PT Novell Pharmaceutical Laboratories, Indonesia

G&H Trading Company 16 July 2019 till 15 July 2024

POM

1980 BRU19072624P Pemirex Injection 100mg Pemetrexed 100mg Korea United Pharm Inc., Republic of Korea

Kingsley Medical Supplies Sdn Bhd

16 July 2019 till 15 July 2024

POM

1981 BRU19072625P Pemirex Injection 500mg Pemetrexed 500mg Korea United Pharm Inc., Republic of Korea

Kingsley Medical Supplies Sdn Bhd

16 July 2019 till 15 July 2024

POM

1982 BRU19072626P Tapcom-S Ophthalmic Solution

Tafluprost 15μg/ml, Timolol 5mg/ml Laboratoire Unither, France Medipharm Sdn Bhd 16 July 2019 till 15 July 2024

POM

1983 BRU19072627P Cyramza 100mg/10ml Concentrate For Solution For Infusion

Ramucirumab 10mg/ml Eli Lilly and Company, USA Zuellig Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1984 BRU19072628P Cyramza 500mg/50ml Concentrate For Solution For Infusion

Ramucirumab 10mg/ml Eli Lilly and Company, USA Zuellig Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1985 BRU19072629P Hydrocortisone cream 1% W/W

Hydrocortisone 1% w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat BumiMedic 16 July 2019 till 15 July 2024

P

1986 BRU19072630NP Microshield 4 Chlorhexidine Surgical Handwash

Chlorhexidine Gluconate 4% w/v Alliance Formulations, India Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

GSL

1987 BRU19072631P Glumil 850mg Tablet Metformin Hydrochloride 850mg The United Drug (1996) Co., Ltd., Thailand

Medicorp Sdn Bhd 16 July 2019 till 15 July 2024

POM

1988 BRU19072632NP Betadine Sore Throat Spray 0.45% w/v

Povidone-Iodine 0.45% w/v Mundipharma Pharmaceuticals Ltd., Cyprus

Zuellig Pharma (B) Sdn. Bhd 16 July 2019 till 15 July 2024

GSL

1989 BRU19072633P Fludarabine Sandoz 50mg/2Ml concentrate FOR Solution for Injection or Infusion

Fludarabine phosphate 50mg/2ml Ebewe Pharma Ges.m.b.H.Nfg.KG, Austria

Zuellig Pharma Sdn Bhd 16 July 2019 till 15 July 2024

POM

1990 BRU19072634P Platol (Cisplatin Concentrate for Solution for Infusion 50mg/50ml)

Cisplatin 50mg/50ml Venus Remedies Limited, India Kingsley Medical Supplies Sdn Bhd

16 July 2019 till 15 July 2024

POM

1991 BRU19072635P Doxorubicin 2mg/ml concentrate for solution for infusion

Doxorubicin hydrochloride 2mg/ml Sichuan Huiyu Pharmaceutical Co., Ltd., China

Kingsley Medical Supplies Sdn Bhd

16 July 2019 till 15 July 2024

POM

1992 BRU19072636P Montelukast Sandoz 10mg Film-coated Tablet

10mg montelukast Sandoz Ilac Sanayi ve Ticaret A.S., Turkey

Zuellig Pharma (B) Sdn Bhd 16 July 2019 till 15 July 2024

POM

BDMCA/RMP/1220 Page 146 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

1993 BRU19072637P Lakan Injection 1% (10ml vial) Lignocaine Hydrochloride 10mg per ml (10ml)

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

1994 BRU19072638P Lakan Injection 2% (10ml vial) Lignocaine Hydrochloride 20mg per ml (10ml)

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

1995 BRU19072639P Zosaar 50mg Tablets Losartan Potassium 50mg China Chemical & Pharmaceutical Co. Ltd., Taiwan

Medicorp Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

1996 BRU19072640P Converium 150mg Tablet Irbesartan 150mg Medochemie Ltd., Cyprus Hongkiat Trading & Co 09 Oct 2019 till 08 Oct 2024 POM

1997 BRU19072641P Adacel®-Polio Vaccine Each dose (0.5 mL) contains: Tetanus Toxoid………… ≥ 20 IU (5 Lf) Diphtheria Toxoid………≥ 2 IU (2 Lf) Acellular Pertussis: Pertussis Toxoid (PT)……………………… 2.5 μg Filamentous Haemagglutinin (FHA)………. 5 μgPertactin (PRN) ……………………………. 3 μg Fimbriae Types 2 and 3 (FIM)………………5 μg Inactivated Poliomyelitis Vaccine (IPV):Type 1 (Mahoney) ………40 D-antigen units*Type 2 (MEF-1) …………8 D-antigen units* Type 3 (Saukett) …………32 D-antigen units*

Sanofi Pasteur Ltd (Canada), Canada

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

1998 BRU19072642P Clozole Cream 1% Clotrimazole 10mg/g SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 09 Oct 2019 till 08 Oct 2024 GSL

1999 BRU19072643P Thelban Tablet Albendazole 200mg Biolab Company Ltd, Thailand Hongkiat Trading & Co 09 Oct 2019 till 08 Oct 2024 P (50 X 2's)GSL (2's)

2000 BRU19072644P Ribomustin 25mg/Vial Powder for Concentrate for Solution for Infusion

Bendamustine hydrochloride 25mg Oncotec Pharma Produktion GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2001 BRU19072645P Ribomustin 100mg/Vial Powder for Concentrate for Solution for Infusion

Bendamustine hydrochloride 100mg Oncotec Pharma Produktion GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2002 BRU19072646P Rydapt 25mg Soft Capsules Midostaurin 25mg Catalent Germany Eberbach GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

BDMCA/RMP/1220 Page 147 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2003 BRU19072647P Tecentriq Concentrate for Solution for Infusion 1200mg/20ml

Atezolizumab 60mg/ml Roche Diagnostics GmbH, Germany

Hongkiat Trading & Co 09 Oct 2019 till 08 Oct 2024 POM

2004 BRU19072648NP Tiger Balm Plaster - RD Camphor BP 1.0% w/wEucalyptus oil BP 0.5% w/wMentha oil (Dementholised Mint Oil) BP 0.6% w/wMenthol BP 0.3% w/wCapsicum Extract JP 0.2% w/w

Haw Par Heatlhcare Ltd, Singapore

Hamitan Marketing 09 Oct 2019 till 08 Oct 2024 GSL

2005 BRU19072649P Carvedilol Sandoz 6.25mg Carvedilol 6.25mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2006 BRU19072650P Carvedilol Sandoz 25mg Carvedilol 25mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2007 BRU19072651P Betacylic Ointment Betamethasone Dipropionate 0.643mg/g (equivalent to Betamethasone 0.5mg/g), Salicylic Acid 30mg/g

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2008 BRU19072652NP Woods Peppermint Cough Syrup

Guaiphenesin 100mg/5ml IDS Manufacturing Sdn Bhd, Malaysia

M.S. Makmur Trading Co 09 Oct 2019 till 08 Oct 2024 GSL

2009 BRU19072653P Gabapentin Sandoz Capsules 300mg

Gabapentin 300mg Sandoz Private Limited, India Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2010 BRU19072654P Aremed 1mg Tablet Anastrozole 1mg Remedica Ltd, Cyprus Kingsley Medical Supplies Sdn Bhd

09 Oct 2019 till 08 Oct 2024 POM

2011 BRU19072655P Uniflex Cream 0.1% w/w Betamethasone (as Betamethasone 17-valerate) 0.1% w/w

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat BumiMedic 09 Oct 2019 till 08 Oct 2024 POM

2012 BRU19072656P Finil 8 Tablet Candesartan cilexetil 8mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2013 BRU19072657NP Shine Cutie Chewable Tablet i) Ascorbic Acid 30mgii) L-Lysine Monohydrochloride 25mg

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 GSL

2014 BRU19082658P Motidone Tablet 10mg Domperidone 10mg Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2015 BRU19082659P Hovid Alendronate 70mg Tablet

Sodium Alendronate Trihydrate 91.4 mg equivalent to 70 mg Alendronic Acid

HOVID Bhd, Malaysia G&H Trading Company 09 Oct 2019 till 08 Oct 2024 POM

2016 BRU19082660P Zobid Injection 3ml Diclofenac Sodium 75mg/3ml SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 09 Oct 2019 till 08 Oct 2024 POM

2017 BRU19082661P Ceftriaxone-AFT Powder for Injection 500mg

Ceftriaxone Sodium 539mg (equivalent to Ceftriaxone 500mg)

Qilu Pharmaceutical Co., Ltd., China

Medipharm Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

BDMCA/RMP/1220 Page 148 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2018 BRU19082662NP Biphozyl Solution for Haemodialysis/Haemofiltration

Small Compartment: Magnesium Chloride Hexahydrate 3.05g/L

Large Compartment: Sodium Chloride 7.01g/LSodium Hydrogen Carbonate 2.12g/LPotassium Chloride 0.314g/LDisodium Phosphate Dihydrate 0.187g/L

Bieffe Medital S.p.A, Italy Medicorp Sdn Bhd 09 Oct 2019 till 08 Oct 2024 GSL

2019 BRU19082663P Exjade 90mg Film-coated Tablet

Deferasirox 90mg Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2020 BRU19082665P Exjade 360mg Film-coated Tablet

Deferasirox 360mg Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2021 BRU19082666P Kanarb 60mg Tablets Fimasartan potassium trihydrate 66.01mg (as fimasartan potassium 60mg)

Boryung Pharmaceutical Co. Ltd., Republic of Korea

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2022 BRU19082667P Kanarb 120mg Tablets Fimasartan potassium trihydrate 132.02mg (as fimasartan potassium120mg)

Boryung Pharmaceutical Co. Ltd., Republic of Korea

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2023 BRU19082668P Ondansetron-AFT Solution for Injection 2mg/ml

Ondansetron 2mg/ml Qilu Pharmaceutical Co., Ltd., China

Medipharm Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2024 BRU19082669P Minirin Tablet 0.1mg Desmopressin Acetate 0.1mg Ferring International Center SA, Switzerland

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2025 BRU19082670P Minirin Tablet 0.2mg Desmopressin Acetate 0.2mg Ferring International Center SA, Switzerland

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2026 BRU19082671NP Dermoplex Antiseptic Cream Cetrimide BP 0.5% w/w Upha Pharmaceutical Mfg (M) Sdn Bhd, Malaysia

Bintang Ria Sdn Bhd 09 Oct 2019 till 08 Oct 2024 GSL

2027 BRU19082672NP Dias Glucosamine 500mg Capsule

Glucosamine sulfate sodium chloride 628mg (containing Glucosamine sulfate 500mg)

Medochemie Ltd, Cyprus Hongkiat Trading & Co 09 Oct 2019 till 08 Oct 2024 GSL

2028 BRU19082673P Atoris Film-Coated Tablet 40mg

Atorvastatin 40mg (as Calcium) KRKA, d.d., Solvenia K-Seri Pharma Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2029 BRU19082674P Avorax Cream Acyclovir 5% w/w Xepa-Soul pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat BumiMedic 09 Oct 2019 till 08 Oct 2024 P

2030 BRU19082675P Letram OS (Levetiracetam Oral Solution 100mg/ml)

Levetiracetam 100mg/ml Hetero Labs Limited (Unit III), India

K-Seri Pharma Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2031 BRU19082676NP Unilac Lactulose 3.3g/5ml Oral Solution USP

Lactulose 3.3g/5ml KCK Pharmaceutical Industries Sdn Bhd, Malaysia

Kingsley Medical Supplies Sdn Bhd

09 Oct 2019 till 08 Oct 2024 GSL - 100ml & 200ml

P- 1000ml (1L)

BDMCA/RMP/1220 Page 149 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2032 BRU19082677NP SENNA 7.5MG TABLET Sennoside 7.5mg Remedica Ltd, Cyprus Kingsley Medical Supplies Sdn Bhd

09 Oct 2019 till 08 Oct 2024 GSL - 60'sP - 100 x 10's

2033 BRU19092678P Flurocort Injection 40mg/ml Triamcinolone Acetonide 40mg/ml SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 09 Oct 2019 till 08 Oct 2024 POM

2034 BRU19092679PS1, BRU19092679PS2

Imbruvica 140mg Capsule Ibrutinib 140mg S1: Catalent CTS, LLC, USAS2: Cilag AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2035 BRU19092680NP Vitabiotics Pregnacare Plus Omega-3 Tablet/Capsule

Each tablet contains:Natural Mixed Carotenoids (as Natural Betacarotene 20% CWD Powder 10.0 mg) 2.00 mg;Thiamin (Vitamin B1) (as Thiamine Mononitrate 3.7 mg) 3.00 mg;Riboflavin (Vitamin B2) (as Riboflavin 2.0 mg) 2.00 mg;Vitamin D3 (as Vitamin D3 100 IU/mg EC 4.0 mg) 10.00 µg);Folacin (Folic Acid) (as Folic Acid 400.0 µg) 400.00 µg;Vitamin K (as Vitamin K1 5% GFT (BASF) 1.4 mg) 70.00 µg;Vitamin B12 (as Cyanocobalamin 0.1% DCP Prep.) 6.0 mg) 6.00 µg;Vitamin B6 (as Pyridoxine Hydrochloride 12.2 mg) 10.00 mg;Pantothenic Acid (as Calcium D-Pantothenate 6.5 mg) 6.00 mg;Biotin (as D-Biotin 150.0 µg) 150.00 µg;Vitamin C (as Ascorbic Acid HPMC (97%) 72.2 mg) 70.00 mg;Vitamin E (as D alphaTocopheryl Acid Succinate 24.6 mg) 20.00 mg;Niacin (Vitamin B3) (as Nicotinamide 20.0 mg) 20.00 mg;Zinc (as Zinc Sulphate Monohydrate 41.2 mg) 15.00 mg;Iron (as Ferrous Fumarate 51.7 mg)

Tablets:Brunel Healthcare Manufacturing Limited, UKCapsules:EuroCaps Limited, UK

Rico Agencies 09 Oct 2019 till 08 Oct 2024 GSL

2036 BRU19092681P Flexin 20mg Capsule Fluoxetin hydrochloride 22.4mg equivalent to Fluoxetin 20mg

SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 09 Oct 2019 till 08 Oct 2024 POM

BDMCA/RMP/1220 Page 150 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2037 BRU19092682P Kanarb Plus 60mg/12.5mg Fimasartan potassium trihydrate 66.01mg (as fimasartan potassium 60mg)Hydrochlorothiazide 12.5mg

Boryung Pharmaceutical Co. Ltd., Republic of Korea

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2038 BRU19092683P Kanarb Plus 120mg/12.5mg Fimasartan potassium trihydrate 132.02mg (as fimasartan potassium120mg) ; Hydrochlorothiazide 12.5mg

Boryung Pharmaceutical Co. Ltd., Republic of Korea

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2039 BRU19092684P Lamictal Chewable Dispersible Tablet 2mg

Lamotrigine 2mg GlaxoSmithKline LLC, USA Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2040 BRU19092685P Curam 1000mg + 200mg Powder for Intravenous Solution

Amoxicillin Sodium eq to Amoxicillin 1g; Potassium Clavulanate eq to Clavulanic Acid 200mg

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2041 BRU19092686P Dexin injection 2ml Each ml contains Dexamethasone Sodium Phosphate equivalent to Dexamethasone Phosphate 4mg/ml

SM Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 09 Oct 2019 till 08 Oct 2024 POM

2042 BRU19092687PS1, BRU19092687PS2, BRU19092687PS3

Insulatard Penfill 100IU/ml Suspension for Injection in Cartridge

1 ml suspension contains 100 IU (3.5 mg) of insulin human (rDNA)

S1: Novo Nordisk, DenmarkS2: Novo Nordisk Production SAS, FranceS3: Novo Nordisk Producäo Farmacêtica do Brasil Ltda., Brazil

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2043 BRU19092688P Maviret Film-Coated Tablets Glecaprevir 100mg / Pibrentasvir 40mg Fournier Laboratories Ireland Ltd., Ireland

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2044 BRU19092689P Gemcitabine Sandoz Concentrate for Solution for Infusion 40mg/ml

Gemcitabine 40mg/ml Ebewe Pharma Ges.m.b.H.Nfg, Austria

Zuellig Pharma Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2045 BRU19092690NP Flexijoint 3-in-1 Joint Care Powder

Each sachet (5.5g) contains: -Glucosamine HCl …………….....1500 mg Chondroitin Sulphate ……………1200mg (derived from Chondrotion Sodium Sulphate 1320.6mg Methylsulfonylmethane (MSM) ...900mg

Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 09 Oct 2019 till 08 Oct 2024 GSL

2046 BRU19092691P Rexom Bromhexine Elixir 4mg/5ml

Bromhexine Hydrochloride 4mg/5ml KCK Pharmaceutical Industries Sdn Bhd, Malaysia

Kingsley Medical Supplies Sdn Bhd

09 Oct 2019 till 08 Oct 2024 P

BDMCA/RMP/1220 Page 151 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2047 BRU19092692P Akynzeo (netupitant / palonosetron) 300mg/0.5mg Hard Capsules

300 mg Netupitant0.5 mg Palonosetron

Helsinn Birex Pharmaceuticals Ltd, Ireland

Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2048 BRU19092693P Aslene Capsule 120mg Orlistat 120mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 09 Oct 2019 till 08 Oct 2024 POM

2049 BRU19092694P Lentronat (Letrozole Tablets USP, 2.5mg

Letrozole 2.5mg Natco Pharma Limited, India MediPharm Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2050 BRU19092695P Viagra 25mg tablet Sildenafil citrate equivalent to 25mg sildenafil

Fareva Amboise, France Zuellig Pharma (B) Sdn Bhd 09 Oct 2019 till 08 Oct 2024 POM

2051 BRU19092696P Vencid Enteric-Coated Tablet 40mg

Pantoprazole 40mg (as Pantoprazole Sodium Sesquihydrate)

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 09 Oct 2019 till 08 Oct 2024 POM

2052 BRU19092697P Breathnine Syrup 2mg/5ml Each 5ml contains Salbutamol Sulphate eq. to Salbutamol 2mg

SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Co 09 Oct 2019 till 08 Oct 2024 POM

2053 BRU19112699P Beathorphan Tablets 15mg Dextromethorphan Hydrobromide BP 15mg

Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 15 Jan2020 till 14 Jan 2025 POM

2054 BRU19112701P Taflotan®-S ophthalmic solution 0.0015%

Tafluprost 0.0015 % (0.015mg/ml) Santen Pharmaceutical Co., Ltd., Noto Plant, Japan

MediPharm Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2055 BRU19112702P Lartil Injection 12.5mg/ml (1ml amp)

Prochlorperazine Mesylate 12.5mg/ml Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2056 BRU19112703NP Calcium Chloride 10% Injection 1g in 10mL

Calcium Chloride Dihydrate 100mg/ml Phebra Pty Ltd, Australia G&H Trading Company 15 Jan2020 till 14 Jan 2025 POM

2057 BRU19112704PS1; BRU19112704PS2; BRU19112704PS3

Actrapid Penfill 100IU/ml, 3ml Cartridge Solution for Injection

Insulin Human (rDNA) - 1 ml solution contains 100IU (3.5mg) of insulin human (rDNA)

1. Novo Nordisk A/S Novo Allẻ, Denmark; 2. Novo Nordisk Production SAS, France, 3. Novo Nordisk Produҫȃo Farmacȇutica do Brasil Ltda., Brazil

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2058 BRU19112705P Uptravi 200mcg Film Coated Tablets

Selexipag 200mcg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2059 BRU19112706P Uptravi 400mcg Film Coated Tablets

Selexipag 400mcg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2060 BRU19112707P Uptravi 600mcg Film Coated Tablets

Selexipag 600mcg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2061 BRU19112708P Uptravi 800mcg Film Coated Tablets

Selexipag 800mcg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2062 BRU19112709P Uptravi 1000mcg Film Coated Tablets

Selexipag 1000mcg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2063 BRU19112710P Uptravi 1200mcg Film Coated Tablets

Selexipag 1200mcg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

BDMCA/RMP/1220 Page 152 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2064 BRU19112711P Uptravi 1400mcg Film Coated Tablets

Selexipag 1400mcg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2065 BRU19112712P Uptravi 1600mcg Film Coated Tablets

Selexipag 1600mcg Excella GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2066 BRU19112713NP Tiger Balm Plus Ointment Camphor 11.0% w/wLevomenthol (Menthol) BP 10% w/wMethyl Salicylate 10% w/wCajuput Oil 7% w/wDementholised Mint Oil 6% w/wClove Oil 5% w/w

Tiger Balm (M) Sdn Bhd, Malaysia

Hamitan Marketing 15 Jan2020 till 14 Jan 2025 GSL

2067 BRU19112714NP Tiger Balm Plaster Per 100gm of the paste:Camphor 1.0% w/wMenthol 0.3% w/wMentha Oil (Dementholised Mint Oil) 0.6% w/wEucalyptus Oil 0.5% w/w

Haw Par Healthcare Ltd., Singapore

Hamitan Marketing 15 Jan2020 till 14 Jan 2025 GSL

2068 BRU19112715NP Microshield® Handrub Chlorhexidine Gluconate 0.5% w/vEthanol 70% v/v

Alliance Formulaions, India Medicorp Sdn Bhd 15 Jan2020 till 14 Jan 2025 GSL

2069 BRU19112716P Glyxambi FIlm-Coated Tablet 10mg/5mg

Empagliflozin 10mgLinagliptin 5mg

Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 15 Jan2020 till 14 Jan 2025 POM

2070 BRU19112717P Glyxambi FIlm-Coated Tablet 25mg/5mg

Empagliflozin 25mgLinagliptin 5mg

Boehringer Ingelheim Pharma GmbH & Co. KG, Germany

Hongkiat Trading & Company 15 Jan2020 till 14 Jan 2025 POM

BDMCA/RMP/1220 Page 153 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2071 BRU19112718NP Shine Multivitamin and Mineral Capsule

Vitamin A Palmitate (= Vit. A 4000IU) …………………….. 4 mgVitamin D3 (= Vit. D3 400IU) ……………………………... 4 mgThiamine Mononitrate ……………………………………… 3 mgRiboflavin …………………………………………………... 2 mgNicotinamide ………………………………………………. 10 mgPyridoxine Hydrochloride (= Pyridoxine 1.7mg) …………..2.07 mgCyanocobalamin ……………………………………………. 5 mcgCalcium Pantothenate (= Pantothenic Acid 10mg) ………10.86 mgCalcium Carbonate Precipitate (= Cal. 250mg) ………… 625 mgAscorbic Acid ……………………………………………… 50 mgFerrous Fumarate (= Iron 20mg) ………………………… 60.8 mgPotassium Iodide (= Iodine 0.15mg) ………………………0.196 mgCopper Sulfate Pentahydrate (= Copper 1mg) . ……… 3.97 mgMagnesium Hydroxide (= Mag. 5mg) …………………… 12 mgManganese Hypophosphite Monohydrate (= Mn. 1mg) …3.693 mgZinc Chloride (= Zinc 1.5mg) ………………………………. 3.13 mgVitamin A Palmitate (= Vit. A 4000IU) …………………….. 4 mgVitamin D3 (= Vit. D3 400IU) ……………………………... 4 mgThiamine Mononitrate ………………………………………

Y.S.P. Industries (M) Sdn Bhd., Malaysia

Asterix United (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 GSL

2072 BRU19112719P Melicron Tablet 80mg Gliclazide 80mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 15 Jan2020 till 14 Jan 2025 POM

2073 BRU19112720P Pemenon 100mg Powder for Concentrate for Solution for Infusion

Each vial contains 100mg of pemetrexed (as pemetrexed disodium)

Gland Pharma Limited, India Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2074 BRU19112721NP Tiger Balm Active Muscle Rub Methyl Salicylate 15% w/wMenthol 5% w/wCamphor 3% w/w

Tiger Balm (M) Sdn Bhd, Malaysia

Hamitan Marketing 15 Jan2020 till 14 Jan 2025 GSL

BDMCA/RMP/1220 Page 154 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2075 BRU19112722NP Tiger Balm Active Muscle Gel Methyl Salicylate 16% w/wMenthol 8% w/w

Tiger Balm (M) Sdn Bhd, Malaysia

Hamitan Marketing 15 Jan2020 till 14 Jan 2025 GSL

2076 BRU19112723P Loraten Tablet 10mg Loratadine 10mg SM Pharmaceuticals Sdn Bhd, Malaysia

G&H Trading Company 15 Jan2020 till 14 Jan 2025 P

2077 BRU19112724P Irinotecan Hydrochloride 20mg/ml concentrate for solution for infusion

Irinotecan Hydrochloride 20mg/ml Sichuan Huiyu Pharmaceutical Ltd, China

Kingsley Medical Supplies Sdn Bhd

15 Jan2020 till 14 Jan 2025 POM

2078 BRU19112725P Torleva 500mg Tablet Levetiracetam 500mg Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2079 BRU19112726P Torleva 250mg Tablet Levetiracetam 250mg Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2080 BRU19112727P Torleva 1000mg Tablet Levetiracetam 1000mg Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2081 BRU19112728P Piperacillin/Tazobactam Sandoz Powder for Solution for Injection/Infusion 4.5g vials

Each vial contains: Piperacillin sodium (corresponding to 4000mg of Piperacillin)Tazobactam sodium (corresponding to 500mg Tazobactam)

Sandoz GmbH, Austria Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2082 BRU19112729P Nexpro Tablet 40mg Esomeprazole Magnesium equivalent to Esomeprazole 40mg

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2083 BRU19112730P Xigduo XR (dapagliflozin /metformin HCl extended-release) tablets 5mg/1000mg

Dapagliflozin Propanediol 5mg Metformin Hydrochloride 1000mg

AstraZeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2084 BRU19112731P Xigduo XR (dapagliflozin /metformin HCl extended-release) tablets 10mg/500mg

Dapagliflozin Propanediol 10mg Metformin Hydrochloride 500mg

AstraZeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2085 BRU19112732P Xigduo XR (dapagliflozin /metformin HCl extended-release) tablets 10mg/1000mg

Dapagliflozin Propanediol 10mg Metformin Hydrochloride 1000mg

AstraZeneca Pharmaceuticals LP, USA

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2086 BRU19112733P Onsia Injection Each ml contains 2mg Ondansetron (as Ondansetron Hydrochloride Dihydrate)

Siam Bheasach Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2087 BRU19112734P Retorin Powder for Suspension 200mg/5ml

Each 5ml contains Erythromycin Ethyl Succinate BP equivalent to Erythromycin 200mg

SM Pharmaceuticals Sdn. Bhd., Malaysia

G&H Trading Company 15 Jan2020 till 14 Jan 2025 POM

2088 BRU19112735P Anastrozole Sandoz Film Coated Tablet 1mg

Anastrozole 1mg Salutas Pharma GmbH, Germany Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

BDMCA/RMP/1220 Page 155 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2089 BRU19112736NP Betadine Vaginal Gel 10% w/w with applicator

Povidone-Iodine 10% w/w Mundipharma Pharmaceuticals Ltd., Cyprus

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 GSL

2090 BRU19112737P Elonza-50 Tablet Sildenafil Citrate equivalent to Sildenafil 50mg

Unison Laboratories Co. Ltd., Thailand

K-Seri Pharma Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2091 BRU19112738P Zenpro Capsule 20mg Omeprazole 20mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd., Malaysia

Syarikat Bumimedic 15 Jan2020 till 14 Jan 2025 POM

2092 BRU19112739P Creobic Gold Cream 1% w/w Terbinafine Hydrochloride 1% w/w Kotra Pharma (M) Sdn Bhd, Malaysia

Yuh Hua Trading Company 15 Jan2020 till 14 Jan 2025 GSL

2093 BRU19122740P Olvion 50mg Film-Coated Tablet

Sildenafil 50mg (as Sildenafil Citrate) Jubilant Life Sciences Ltd, India Hongkiat Trading & Company 15 Jan2020 till 14 Jan 2025 POM

2094 BRU19122741P SKYCellflu Quadrivalent Pre-filled Syringe

Per 0.5ml prefilled syringe contains pure inactivated Influenza virus surface antigens: Purified inactivated influenza virus surface antigen [A/Brisbane/02/2018, IVR-190(H1N1)]……………………..15µg Purified inactivated influenza virus surface antigen [A/Kansas/14/2017, IVR-195 (H3N2)]………….…………...15µg Purified inactivated influenza virus surface antigen [B/Maryland/15/2016]……..………………………………….15µg Purified inactivated influenza virus surface antigen [B/Phuket/3073/2013]………………………………………...15µg

SK Bioscience Co., Ltd, Republic of Korea

MediPharm Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2095 BRU19122742NP Biotase Chewable Tablet Biodiastase #1000 – 30mgLipase AP6 – 5mgNewlase – 10mg

Y.S.P. Industries (M) Sdn. Bhd., Malaysia

Asterix United (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 GSL

2096 BRU19122743P Lodipin Tablet 10mg Amlodipine Besilate BP 13.9mg equivalent to Amlodipine 10mg

Ind-Swift Limited. Off. NH-21, India

Medicorp Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2097 BRU19122744P Lodipin Tablet 5mg Amlodipine Besilate BP 6.95mg equivalent to Amlodipine 5mg

Ind-Swift Limited. Off. NH-21, India

MediCorp Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

BDMCA/RMP/1220 Page 156 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2098 BRU19122745NP Phoxilium 1.2 mmol/l Phosphate Solution For Haemodialysis /Haemofiltration

Small Compartment A (electrolyte solution)Calcium Chloride Dihydrate 3.675g/L Magnesium Chloride Hexahydrate 2.440g/L

Large Compartment B (buffer solution)Sodium Chloride 6.435g/LSodium Hydrogen Carbonate 2.918g/LPotassium Chloride 0.314g/LDisodium Phosphate Dihydrate 0.225g/L

Bieffe Medital S.p.A., Italy Medicorp Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2099 BRU19122746PS1, BRU19122746PS2

Bisohexal Tablet 5mg Bisoprolol fumarate 5mg 1. Salutas Pharma GmbH, Germany 2. Lek S.A., 16, , Poland

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2100 BRU19122747P Azamun 50mg Tablet Azathioprine 50mg Douglas Manufacturing Ltd, New Zealand

K-Seri Pharma Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2101 BRU19122748P Candesartan Sandoz Tablet 16mg

Candesartan Cilexetil 16mg Lek Pharmaceuticals d.d., Slovenia

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2102 BRU19122749P Concor AM 5mg / 10mg Tablet i) Bisoprolol Fumarate 5mgii) Amlodipine 10mg (as Amlodipine Besilate 13.9mg)

EGIS Pharmaceuticals PLC, Hungary

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2103 BRU19122750P Pregabalin Sandoz 75mg Capsules

Pregabalin 75mg Sandoz Ilac Sanayi ve Ticaret A.S., , Turkey

Zuellig Pharma (B) Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2104 BRU19122751P Gentamicin-POS Eye Drops 1ml contains: Gentamicin Sulphate 5mg (3mg Gentamicin)

Ursapharm Arzneimittel Gmbh & Co Kg, Germany

Medicorp Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2105 BRU19122752P Airflusal® Forspiro 50/250mcg Salmeterol (as Salmeterol Xinafoate) 50mcg / Fluticasone Propionate 250mcg

Aeropharm GmbH, Germany Zuellig Pharma Sdn Bhd 15 Jan2020 till 14 Jan 2025 POM

2106 BRU19122753NP Actimol Menstrual Tablet i) Paracetamol 500mgii) Pamabrom 25mg

Pharmaniaga Manufacturing Berhad, Malaysia

G&H Trading Company 15 Jan2020 till 14 Jan 2025 10'S & 20'S - GSL 100'S & 1000'S - P

2107 BRU20012754NP Eye Glo Regular Eye Drops 1.Boric Acid 1%w/v2.Borax 0.25%w/v

Duopharma (M) Sdn. Bhd., Malaysia

Bintang Ria Sdn. Bhd. 22 April 2020 till 21 April 2025

GSL

2108 BRU20012755P Axcel Ketotifen Syrup Each 5ml contains Ketotifen Hydrogen Fumarate equivalent to Ketotifen 1mg

Kotra Pharma (M) Sdn. Bhd., Malaysia

Medicorp Sdn. Bhd. 22 April 2020 till 21 April 2025

POM

2109 BRU20012756P Fusix Tablet 40mg Frusemide 40mg SM Pharmaceuticals Sdn. Bhd., Malaysia

G & H Trading Company 22 April 2020 till 21 April 2025

POM

BDMCA/RMP/1220 Page 157 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2110 BRU20012757P Non-Preg Injection Each vial of 3ml contains Medroxyprogesterone Acetate 150mg

L.B.S Laboratory Ltd., Part., Thailand

Medicorp Sdn. Bhd 22 April 2020 till 21 April 2025

POM

2111 BRU20012758P Bisloc 5 Tablet Bisoprolol Fumarate 5mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn. Bhd., 22 April 2020 till 21 April 2025

POM

2112 BRU20012759P Comazole N Tablet Sulphamethoxazole 400mg Trimethoprim 80mg

SM Pharmaceutical Sdn. Bhd., Malaysia.

G & H Trading Company 22 April 2020 till 21 April 2025

POM

2113 BRU20012760P QUANTIA 25 Film Coated Tablet

Quetiapine fumarate 28.7825mg equivalent to Quetiapine 25mg

Unison Laboratories Co., Ltd, Thailand

K-Seri Pharma Sdn Bhd. 22 April 2020 till 21 April 2025

POM

2114 BRU20012761P QUANTIA 100 Film Coated Tablet

Quetiapine fumarate 115.130mg equivalent to Quetiapine 100mg

Unison Laboratories Co., Ltd, Thailand

K-Seri Pharma Sdn Bhd. 22 April 2020 till 21 April 2025

POM

2115 BRU20012762P QUANTIA 200 Film Coated Tablet

Quetiapine fumarate 230.260mg equivalent to Quetiapine 200mg

Unison Laboratories Co., Ltd, Thailand

K-Seri Pharma Sdn Bhd. 22 April 2020 till 21 April 2025

POM

2116 BRU20012763NP IFIMOL IV (Paracetamol Solution for Intravenous Infusion 10mg/ml)

Paracetamol 10mg/ml Unique Pharmaceutical Laboratories, India

K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2117 BRU20012764P Sofilex Capsule 250mg Cephalexin monohydrate equivalent to Cephalexin 250mg

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat BumiMedic 22 April 2020 till 21 April 2025

POM

2118 BRU20012765P Cavumox 1.2g Injection Amoxicillin (as Sodium) 1.0g & Clavulanic Acid (as Potasssium Salt) 0.2g

Siam Bheasach Co., Ltd. Thailand K-Seri Pharma Sdn. Bhd. 22 April 2020 till 21 April 2025

POM

2119 BRU20012766P Combiwave SF 125 (Salmeterol 25mcg/actuation and Fluticasone Propionate 125mcg/actuation pressurised inhalation)

Each actuation delivers: Salmeterol Xinafoate BP equivalent to Salmeterol 25mcg; Fluticasone Propionate BP 125mcg

Glenmark Pharmaceuticals Limited, India

Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2120 BRU20012767P Combiwave SF 250 (Salmeterol 25mcg/actuation and Fluticasone Propionate 250mcg/actuation pressurised inhalation)

Each actuation delivers: Salmeterol Xinafoate BP equivalent to Salmeterol 25mcg; Fluticasone Propionate BP 250mcg

Glenmark Pharmaceuticals Limited, India

Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

BDMCA/RMP/1220 Page 158 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2121 BRU20012768P Salbutamol Sandoz 100mcg/dose pressurised inhalation

One metered dose contains 120 micrograms of salbutamol sulphate equivalent to 100 micrograms of salbutamol.The delivered dose through the mouthpiece contains 108 micrograms of salbutamol sulphate equivalent to 90 micrograms of salbutamol (as sulphate).

Aeropharm GmbH, Germany Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2122 BRU20012769P COVASTIN TABLET 20MG Simvastatin 20mg Xepa-Soul Pattinson (Malaysia), Malaysia

Syarikat BumiMedic 22 April 2020 till 21 April 2025

POM

2123 BRU20012770NP FlameX Suspension Sodium Alginate 250mg/5ml, Dried Aluminium Hydroxide 100mg/5ml, Calcium Carbonate 75mg/5ml

KCK Pharmaceutical Industries Sdn Bhd, Malaysia

Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

GSL

2124 BRU20012771P Letrozole Mevon Tablet 2.5mg Letrozole 2.5mg Atlas Pharma SA, Morocco. Kingsley Medical Supplies Sdn Bhd.

22 April 2020 till 21 April 2025

POM

2125 BRU20012772P Flucozole (Intravenous Infusion) 2mg/ml

Fluconazole 2mg/ml Siam Bheasach Co. Ltd., Thailand K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2126 BRU20022773NP PATENT BLUE V SODIUM GUERBET 2.5%

Patent Blue V Sodium 2.5% Delpharm Tours, France Manning Jaya Trading (B) Sdn Bhd

22 April 2020 till 21 April 2025

POM

2127 BRU20022774P Micosten Cream 2% Miconazole Nitrate Micronised (100%) 20mg/1g

Noripharma Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

GSL

2128 BRU20022775P Mobitil Injection 20ml Vial Dobutamine HCl BP equivalent to Dobutamine 12.5mg/ml

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2129 BRU20022776P Fytosid Injection 20mg/ml Etoposide 20mg /ml Fresenius Kabi Oncology Limited, India

Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2130 BRU20022777P Fleming Oral Suspension (457mg/5ml)

Each 5 ml after reconstitution contains:• Amoxicillin Trihydrate BP equivalent to Amoxicillin 400 mg• Potassium Clavulanate BP (as diluted Potassium Clavulanate BP) equivalent to Clavulanic acid 57 mg

Medreich Limited, India Medicorp Sdn Bhd 22 April 2020 till 21 April 2025

POM

2131 BRU20022778P Repatha Solution for Injection in Prefilled Syringe 140mg/ml

Evolocumab 140mg/ml Amgen Manufacturing Limited, USA

MediPharm Sdn Bhd 22 April 2020 till 21 April 2025

POM

2132 BRU20022779P Repatha Solution for Injection in Prefilled Autoinjector 140mg/ml

Evolocumab 140mg/ml Amgen Manufacturing Limited, USA

MediPharm Sdn Bhd 22 April 2020 till 21 April 2025

POM

BDMCA/RMP/1220 Page 159 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2133 BRU20022780P Pemetrexed Seacross 500mg Powder for Concentrate for Solution for Infusion

Each vial contains Pemetrexed 500mg (as Pemetrexed Disodium)

Sichuan Huiyu Pharmaceutical Co. Ltd, China

Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2134 BRU20022781P Pemetrexed Seacross 100mg Powder for Concentrate for Solution for Infusion

Each vial contains Pemetrexed 100mg (as Pemetrexed Disodium)

Sichuan Huiyu Pharmaceutical Co. Ltd, China

Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2135 BRU20022782P Pemenon 500mg Powder for Concentrate for Solution for Infusion

Pemetrexed (as pemetrexed sodium) 500mg

Gland Pharma Limited, India Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2136 BRU20022783P Momate Nasal Spray 50mcg Mometasone Furoate Monohydrate equivalent to Mometasone Furoate 0.05% w/w

Glenmark Pharmaceuticals Ltd., India

Kingsley Medical Supplies 22 April 2020 till 21 April 2025

POM

2137 BRU20022784P Somidem Tablet 10mg Zolpidem Tartrate 10mg Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2138 BRU20022785P Ibicar 100 (Beclometasone Pressurised Inhalation BP 100µg/actuation)

Beclometasone Dipropionate Anhydrous EP 100μg/actuation

Glenmark Pharmaceuticals Ltd., India

Kingsley Medical Supplies 22 April 2020 till 21 April 2025

POM

2139 BRU20022786NP Tonbien Solution Jen Sheng 150mg/ml

Each ml contains Sodium Chloride 150mg

Jen Sheng Pharmaceutical Co. Ltd., Taiwan

Chop Khong Lin Dispensary 22 April 2020 till 21 April 2025

GSL

2140 BRU20022787P Apo-Allopurinol Tablet 300mg Allopurinol 300mg Apotex Inc, Canada Medicorp Sdn Bhd 22 April 2020 till 21 April 2025

POM

2141 BRU20022788P Azimax 250mg Tablet Azithromycin Dihydrate 262.05mg (equivalent to Azithromycin 250mg)

Hovid Bhd, Malaysia G&H Trading Company 22 April 2020 till 21 April 2025

POM

2142 BRU20032789P Kisan Injection 10mg/ml Vitamin K1 (Phytomenadione) 10mg/ml Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2143 BRU20032790P Basalog one Insulin Glargine Injection (rDNA origin) 100 IU/mL Prefilled Pen

Each mL of prefilled pen contains: Insulin Glargine (rDNA origin) 100 IU/mL

Biocon Limited, India K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2144 BRU20032791P Tasigna 50mg capsule Nilotinib (as hydrochloride monohydrate) 50mg

Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2145 BRU20032792P Lochol 10mg Tablet Simvastatin 10mg Siam Bheasach Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2146 BRU20032793P Xgeva Solution for Injection 120mg/vial

Each vial contains 120mg of denosumab in 1.7ml of solution (70mg/ml)

Amgen Manufacturing Limited (AML), United States

MediPharm Sdn Bhd 22 April 2020 till 21 April 2025

POM

2147 BRU20032794P Rekaxime Injection 1000mg Cefotaxime Sodium equivalent to Cefotaxime 1000mg

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2148 BRU20032795P Setisin Injection 2.5mg/ml (1ml Amp)

Neostigmine Methylsulphate BP 2.5mg/ml

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2149 BRU20032796P Avarin Softgel Capsule Alverine Citrate 60mg & Simeticone 300mg

Mega Lifesciences Public Company Limited, Thailand

Hongkiat Trading & Company 22 April 2020 till 21 April 2025

POM

2150 BRU20032797P MENOPUR® Multidose 600iu Powder and Solvent for Solution for Injection

Each vial with powder contains highly purified menotrophin (human menopausal gonadotrophin, HMG) corresponding to follicle stimulating hormone activity FSH 600 IU and luteinizing hormone activity LH 600 IU

Ferring GmbH, Germany Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2151 BRU20032798P Fleming Oral Suspension (228.5mg/5ml)

Each 5 ml after reconstitution contains:•Amoxicillin Trihydrate BP equivalent to Amoxicillin 200 mg•Potassium Clavulanate BP equivalent to Clavulanic acid 28.5 mg

Medreich Limited, India Medicorp Sdn Bhd 22 April 2020 till 21 April 2025

POM

2152 BRU20032799P Netil Injection Netilmicin sulfate equivalent to Netilmicin base 50mg/ml

Siam Bheasach Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2153 BRU20032800P Vivocin (Vancomycin Hydrochloride for Injection USP 500mg/Vial)

Vancomycin Hydrochloride USP equivalent to Vancomycin 500mg

Gland Pharma Limited, India Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2154 BRU20032801P Humira Solution for Injection in pre-filled syringe 80mg/0.8ml

Adalimumab 80mg/0.8ml Vetter Pharma-Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2155 BRU20032802P Humira Solution for Injection in pre-filled pen 80mg/0.8ml

Adalimumab 80mg/0.8ml Vetter Pharma-Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2156 BRU20032803NP Betadine Antiseptic Cream 5% w/w

Povidone-Iodine 5.0% w/w Mundipharma Pharmaceuticals Ltd, Cyprus

Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

GSL

2157 BRU20032804P Kytron Solution for Injection/Infusion 3mg/3ml

Granisetron Hydrochloride equivalent to Granisetron 3mg/3ml

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 22 April 2020 till 21 April 2025

POM

2158 BRU20032805P Nerlynx 40mg Film-Coated Tablet

Neratinib (as Maleate) 40mg Excella GmbH & Co. KG, Germany

Hongkiat Trading & Company 22 April 2020 till 21 April 2025

POM

2159 BRU20032806P Penrazol Powder for Solution for Infusion 40mg/Vial

Omeprazole 40mg (equivalent to Omeprazole Sodium 42.60mg)

Elpen Pharmaceutical Co. Inc, Greece

G&H Trading Company 22 April 2020 till 21 April 2025

POM

2160 BRU20032807P Pospenem Powder for Solution for Injection 500mg

Meropenem 500mg (as Meropenem Trihydrate 570mg)

JW Pharmaceutical Corporation, South Korea

Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2161 BRU20032808P Pospenem Powder for Solution for Injection 1g

Meropenem trihydrate 1,141mg equivalent to Meropenem 1g

JW Pharmaceutical Corporation, South Korea

Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

BDMCA/RMP/1220 Page 161 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2162 BRU20032809P Ebetaxel Injection 6mg/ml Paclitaxel 6mg/ml Ebewe Pharma Ges.m.b.H Ngf.KG, Austria

Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2163 BRU20032810P Imarem 400mg Tablet Imatinib 400 mg (as mesilate) Remedica Limited, Cyprus Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2164 BRU20032811P Imarem 100mg Tablet Imatinib 100 mg (as mesilate) Remedica Limited, Cyprus Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2165 BRU20032812P Pharmidea Carbetocin 100mcg/ml

Carbetocin 100mcg/ml Pharmidea Sia, Latvia Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2166 BRU20032813P Aurasert Tablet 50mg Sertraline Hydrochloride eq. to Sertraline 50mg

Aurobindo Pharma Limited, India Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2167 BRU20032814P Aurasert Tablet 100mg Sertraline Hydrochloride eq. to Sertraline 100mg

Aurobindo Pharma Limited, India Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2168 BRU20032815NP Septidin 10% Solution Povidone Iodine 10% w/v Pahang Pharmacy Sdn Bhd, Malaysia

G & H Trading Company 22 April 2020 till 21 April 2025

GSL

2169 BRU20032816P Prepenem 500mg Injection Imipenem 530mg (equivalent to Imipenem Anhydrous 500mg) Cilastatin Sodium 532mg (equivalent to Cilastatin 500mg)

JW Pharmaceutical Corporation, South Korea

Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2170 BRU20032817P Betaloc ZOK 25mg Tablet Metoprolol Succinate 23.75mg corresponding to Metoprolol Tartrate 25mg

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2171 BRU20032818P Betaloc ZOK 50mg Tablet Metoprolol Succinate 47.5mg corresponding to Metoprolol Tartrate 50mg

AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 22 April 2020 till 21 April 2025

POM

2172 BRU20032819P MYODEEN Adenosine Injection USP 3mg/ml

Adenosine USP 3mg/ml Gland Pharma Limited, India Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2173 BRU20032820P Cravit Ophthalmic Solution 1.5% w/v

Levofloxacin Hydrate 1.5% w/v Santen Pharmaceutical Co., Ltd, Japan

MediPharm Sdn Bhd 22 April 2020 till 21 April 2025

POM

2174 BRU20032821P Supirocin Ointment 2% w/w Mupirocin USP 2% w/w Glenmark Pharmaceuticals Limited, India

Kingsley Medical Supplies Sdn Bhd

22 April 2020 till 21 April 2025

POM

2175 BRU20032822NP Minyak Urut GPU (Gosok-Pijat-Urut) - Minyak Jahe

i) Methyl Salicylate 20.00% ii) Camphor 9.00% iii) Ginger Oil 7.50% iv) Menthol 3.00% v) Eucalyptus Oil 2.50%

PT Eagle Indo Pharma, Indonesia SP Setia Sdn Bhd 22 April 2020 till 21 April 2025

GSL

2176 BRU20042823PS1, BRU20042823PS2

Darzalex 100mg/5ml (20mg/ml) Concentrate for Solution for Infusion

Each vial of 5ml concentrate contains 100mg of daratumumab (20mg/ml)

1) Cilag A.G., Switzerland2) Vetter Pharma Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

BDMCA/RMP/1220 Page 162 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2177 BRU20042824PS1, BRU2004284PS2

Darzalex 400mg/20ml (20mg/ml) Concentrate for Solution for Infusion

Each vial of 20ml concentrate contains 400mg of daratumumab (20mg/ml)

1) Cilag A.G., Switzerland2) Vetter Pharma Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2178 BRU20042825P Malon Injection 2ml Amp Metoclopramide Hydrochloride 10mg/2ml

Duopharma (M) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2179 BRU20042826P GC FLU pre-filled syringe inj. 1 pre-filled syringe 0.5mL containsActive ingredient:Purified Inactive Influenza Virus Antigen…….. 45µgA/Brisbane/02/2018 IVR-190 (H1N1)………... 15µgA/Kansas/14/2017 NYMC X-327 (H3N2)……. 15µgB/Maryland/15/2016 NYMC BX-69A………... .15µg

Green Cross Corporation, Republic of Korea

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2180 BRU20042827P Thyrosit 100 mcg Tablet Thyroxine Sodium 100mcg Sriprasit Pharma Co. Ltd., Thailand

Medicorp Sdn Bhd 19 August 2020 till 18 August 2025

POM

2181 BRU20042828P Lecetam 250 Tablet Levetiracetam 250mg Unison Laboratories Co., Ltd, Thailand

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2182 BRU20042829P Pulmicort Respules 0.5mg/ml Budesonide 0.5mg/ml AstraZeneca AB, Sweden Zuellig Pharma (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2183 BRU20042830NP Geliga Muscular Balm i) Methyl Salicylate 29.95%ii) Peppermint Oil 18.50%iii) White Camphor Oil 12.50%

PT Eagle Indo Pharma, Indonesia SP Setia Sdn Bhd 19 August 2020 till 18 August 2025

GSL

2184 BRU20042831NP Minyak Urut GPU (Gosok-Pijat-Urut) - Minyak Sereh

i) Methyl Salicylate 28.00%ii) Camphor 9.00%iii) Citronella Oil 7.50%iv) Menthol 3.00%v) Eucalyptus Oil 2.50%

PT Eagle Indo Pharma, Indonesia SP Setia Sdn Bhd 19 August 2020 till 18 August 2025

GSL

2185 BRU20042832P Ceritec Syrup 1mg/ml Cetirizine Hydrochloride 1mg/ml Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 19 August 2020 till 18 August 2025

P

2186 BRU20042833P Nexpro Tablets 20mg Esomeprazole 20mg Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2187 BRU20042834NP Rexom Potassium Citrate Mixture

Potassium Citrate BP 1.5gm/5ml & Citric Acid Anhydrous BP 250mg/5ml

KCK Pharmaceutical Industries Sdn Bhd, Malaysia

Kingsley Medical Supplies Sdn Bhd

19 August 2020 till 18 August 2025

GSL

BDMCA/RMP/1220 Page 163 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2188 BRU20042835P SVOZ (0.5% Ophthalmic Solution)

Moxifloxacin 5mg/ml (as Moxifloxacin Hydrochloride 5.45mg/ml)

Siam Bheasach Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2189 BRU20042836P Disuf Ointment 2% w/w Sodium Fusidate (Micronised) 2% w/w Hovid Bhd., Malaysia G & H Trading Company 19 August 2020 till 18 August 2025

POM

2190 BRU20042837P Allopurinol Tablet 100mg Allopurinol 100mg Hovid Bhd., Malaysia G & H Trading Company 19 August 2020 till 18 August 2025

POM

2191 BRU20042838P Virest 5% Cream Aciclovir 5% w/w Hovid Bhd., Malaysia G & H Trading Company 19 August 2020 till 18 August 2025

P

2192 BRU20052839P Conpanzole enteric coated tablet 20mg

Pantoprazole 20mg (as pantoprazole sodium)

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2193 BRU20052840P Conpanzole enteric coated tablet 40mg

Pantoprazole 40mg (as pantoprazole sodium)

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2194 BRU20052841P Tensiber Film Coated Tablet 150mg

Irbesartan 150mg Lek Pharmaceuticals d.d., Slovenia

Zuellig Pharma (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2195 BRU20052842P Unitrexate Tablet 2.5mg Methotrexate 2.5mg Korea United Pharm, Inc., Republic of Korea

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2196 BRU20052843NP Hovid-Paracetamol Suspension 250mg/5ml (Sugar Free)

Paracetamol 250mg/5ml HOVID Bhd., Malaysia G & H Trading Company 19 August 2020 till 18 August 2025

GSL

2197 BRU20052844P A-Losartan 50mg Tablet Losartan Potassium 50mg Pharmathen S.A., Greece Kingsley Medical Supplies Sdn Bhd

19 August 2020 till 18 August 2025

POM

2198 BRU20052845P A-Losartan 100mg Tablet Losartan Potassium 100mg Pharmathen S.A., Greece Kingsley Medical Supplies Sdn Bhd

19 August 2020 till 18 August 2025

POM

2199 BRU20052846P Fustadin Cream 2% w/w Fusidic Acid 2% w/w Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2200 BRU20052847P Peace DM Syrup Each 5ml contains:Triprolidine Hydrochloride 1.25mgPseudoephedrine Hydrochloride 30mgDextromethorphan Hydrobromide 15mg

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 19 August 2020 till 18 August 2025

P

2201 BRU20052848NP Wintinea Cream Tolnaftate 1.0% w/w Winwa Medical Sdn Bhd, Malaysia

Yuh Hua Trading Company 19 August 2020 till 18 August 2025

GSL

2202 BRU20052849P Losartan + HCT Mevon Tablet 100/25mg

Losartan Potassium 100mg & Hydrochlorothiazide 25mg

Pharmathen S.A., Greece Kingsley Medical Supplies Sdn Bhd

19 August 2020 till 18 August 2025

POM

2203 BRU20052850P Bencodyl Linctus Ammonium Chloride BP 135mg/5ml & Diphenhydramine Hydrochloride BP 14mg/5ml

KCK Pharmaceutical Industries Sdn Bhd, Malaysia

Kingsley Medical Supplies Sdn Bhd

19 August 2020 till 18 August 2025

POM

BDMCA/RMP/1220 Page 164 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2204 BRU20052851P Defuzin-B Cream Fusidic Acid 2% w/w & Betamethasone 0.10% w/w (as Betamethasone 17-Valerate)

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 19 August 2020 till 18 August 2025

POM

2205 BRU20052852P Pharmaniaga Simvastatin Tablet 20mg

Simvastatin 20mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 19 August 2020 till 18 August 2025

POM

2206 BRU20052853P Torio 40 Tablet Simvastatin 40mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2207 BRU20062854P Basalog Insulin Glargine Injection (rDNA origin) 100IU/mL

Insulin Glargine 100 IU/ml Biocon Limited, India K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2208 BRU20062855P Gilenya 0.25mg Hard Capsule Fingolimod 0.25mg (corresponding to 0.28mg Fingolimod Hydrochloride)

Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2209 BRU20062856P Zoledronic Acid 5mg/100ml Solution for Infusion

Zoledronic Acid (as Monohydrate) 5mg/100ml

Sichuan Huiyu Pharmaceutical Co. Ltd., China

Kingsley Medical Supplies Sdn Bhd

19 August 2020 till 18 August 2025

POM

2210 BRU20062857NP Wellmex Atomic Enema Each 100ml contains sodium chloride 15g

Health Chemical Pharmaceutical Co., Ltd., Taiwan (R.O.C)

SWL Biomed Sales & Services 19 August 2020 till 18 August 2025

GSL

2211 BRU20062858P Vacodil 25mg Tablets Carvedilol 25mg Aurobindo Pharma Limited, India K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2212 BRU20062859P Mementor Tablets 10mg Memantine Hydrochloride 10mg equivalent to 8.31mg Memantine

Torrent Pharmaceuticals Limited, India

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2213 BRU20062860P Covastin Tablet 40mg Simvastatin 40mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 19 August 2020 till 18 August 2025

POM

2214 BRU20062861P Myborte 3.5mg (Bortezomib Powder for Solution for Injection 3.5mg/Vial)

Bortezomib 3.5mg Dr. Reddy’s Laboratories Limited, India

G & H Trading Company 19 August 2020 till 18 August 2025

POM

2215 BRU20062862P Rivasta 1.5mg Capsule Rivastigmine (as Hydrogen Tartrate) 1.5mg

Siam Bheasach Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2216 BRU20062863P YSP Salbutamol Injection 0.5mg/ml

Salbutamol Sulfate 0.6mg/ml (equivalent to Salbutamol 0.5mg/ml)

Y.S.P. Indutries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2217 BRU20062864P YSP Bufencon Injection Each ml contains:Betamethasone Dipropionate 6.43mg (equivalent to Betamethasone 5.0mg)Betamethasone Sodium Phosphate 2.63mg (equivalent to Betamethasone 2.0mg)

Y.S.P. Indutries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2218 BRU20062865P FInil 16 Tablet Candesartan Cilexetil 16mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bh 19 August 2020 till 18 August 2025

POM

BDMCA/RMP/1220 Page 165 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2219 BRU20062866NP ActiMol Tablet 650mg Paracetamol 650mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 19 August 2020 till 18 August 2025

P

2220 BRU20062867NP BAGES Cream Each 100g contains:Methyl Salicylate 30mgMenthol 10mgCamphor 4mg

Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

GSL

2221 BRU20062868P Lorsedin Oral Solution 1mg/ml Loratadine 1mg/ml Siam Bheasach Co., Ltd, Thailand K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

P

2222 BRU20052869P Albumin (Human) U.S.P. Albutein 5%

Albumin (Human) 5%

- Each vial of 250ml contains 12.5g Albumin (Human) in aqueous diluent- Each vial of 500ml contains 25g Albumin (Human) in aqueous diluent

Grifols Biologicals LLC, USA Hongkiat Trading & Co 19 August 2020 till 18 August 2025

POM

2223 BRU20062870P Mico Cream Miconazole Nitrate 2% w/w KCK Pharmaceutical Industries Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

GSL

2224 BRU20062871P Sunvasc 5 Tablet Amlodipine Besylate 6.934 mg equivalent to Amlodipine 5mg

Sunward Pharmaceutical Sdn Bhd, Malaysia

G & H Trading Company 19 August 2020 till 18 August 2025

POM

2225 BRU20062872P Sensitamine Tablet Chlorpheniramine Maleate 4mg SM Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 19 August 2020 till 18 August 2025

P

2226 BRU20062873P Uniflex-N Cream Betamethasone (as Betamethasone 17-Valerate) 0.10% w/wNeomycin Sulphate 0.50% w/w

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 19 August 2020 till 18 August 2025

POM

2227 BRU20062874P Orata 0.5 film coated tablet Entecavir Monohydrate equivalent to Entecavir 0.5mg

Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2228 BRU20062875NP INFUSOL DS Intravenous Infusion

Dextrose Anhydrous BP 50 g/L Ain Medicare Sdn Bhd, Malaysia Syarikat Pakatan Indah 19 August 2020 till 18 August 2025

GSL

2229 BRU20062876P Podoxred (Pemetrexed) Powder for Concentrate for Solution for Infusion 100mg

Pemetrexed Disodium equivalent to Pemetrexed 100mg

Dr. Reddy’s Laboratories Limited, India

G & H Trading Company 19 August 2020 till 18 August 2025

POM

2230 BRU20062877P Podoxred (Pemetrexed) Powder for Concentrate for Solution for Infusion 500mg

Pemetrexed Disodium equivalent to Pemetrexed 500mg

Dr. Reddy’s Laboratories Limited, India

G & H Trading Company 19 August 2020 till 18 August 2025

POM

2231 BRU20072878NP Kwan Loong Minyak Angin Methyl Salicylate BP 21.0% w/wEucalyptus Oil BP 15.0% w/wMenthol BP 14.0% w/w Camphor BP 10.0% w/w

Tiger Balm (M) Sdn Bhd, Malaysia

Hamitan Marketing 19 August 2020 till 18 August 2025

GSL

BDMCA/RMP/1220 Page 166 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2232 BRU20072879P Nifecard XL Tablet 30mg Nifedipine, USP 30mg Lek Pharmaceutical D.D., Italy Zuellig Pharma (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2233 BRU20072880P Tirlor 10mg tablet Loratadine 10mg Novartis (Bangladesh) Limited, Bangladesh

Zuellig Pharma (B) Sdn Bhd 19 August 2020 till 18 August 2025

P

2234 BRU20072881P Alecensa 150mg hard capsule Alectinib 150mg (equivalent to Alectinib Hydrochloride 161.3mg)

Excella GmbH & Co. KG, Germany

Hong Kiat Trading Company 19 August 2020 till 18 August 2025

POM

2235 BRU20072882NP Dermoplex Burn-Aid Cream Acriflavine 0.1% w/w Duopharma Sdn Bhd, Malaysia Bintang Ria Sdn Bhd 19 August 2020 till 18 August 2025

GSL

2236 BRU20072883P Avoxred (Azacitidine) Powder for Suspension for injection 100mg/vial

Azacitidine 100mg Dr Reddy’s Laboratories Limited, India

G & H Trading Company 19 August 2020 till 18 August 2025

POM

2237 BRU20072884P Redtibin (Decitabine) Powder for Injection 50mg/vial

Decitabine 50mg Dr Reddy’s Laboratories Limited, India

G & H Trading Company 19 August 2020 till 18 August 2025

POM

2238 BRU20072885P Stelara 130mg/26ml Concentrate for solution for infusion

Ustekinumab 130mg/26ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2239 BRU20072886P Besomid 100mcg/actuation HFA-Metered Dose Inhaler

Beclometasone Dipropionate 100mcg/Actuation

Midas Pharmaceuticals Pvt.Ltd., India

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2240 BRU20072887P Timo-COMOD 0.5% eyedrops 1ml solution contains:Timolol Maleate 6.84mg (equivalent to 5.0mg of Timolol)

Ursapharm Arzneimittel GmbH, Germany

Medicorp Sdn Bhd 19 August 2020 till 18 August 2025

POM

2241 BRU20072888P Granisetron Kabi 1mg/ml concentrate solution injection / infusion

Granisetron (as Granisetron Hydrochloride) 1mg/ml

Labesfal-Laboratories Almiro, Portugal

Zuellig Pharma (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2242 BRU20072889NP Unidine Povidone Iodine Solution 10% w/v

Povidone Iodine 10% w/v (equivalent to 1% w/v Available Iodine)

KCK Pharmaceutical Industries Sdn Bhd, Malaysia

Kingsley Medical Supplies Sdn Bhd

19 August 2020 till 18 August 2025

GSL

2243 BRU20072890P Ikervis 1mg/ml eyedrops, emulsion

Ciclosporin 1mg/ml Excelvision, France Medipharm Sdn Bhd 19 August 2020 till 18 August 2025

POM

2244 BRU20072891P Dezor Plus Shampoo Ketoconazole 2.0% w/wZinc Pyrithione 1.0% w/w

Hoe Pharmaceuticals Sdn Bhd, Malaysia

G & H Trading Company 19 August 2020 till 18 August 2025

GSL

2245 BRU20072892P Atorvin 40 Film-coated tablet Atorvastatin Calcium equivalent to Atorvastatin 40mg

Unison Laboratories Co., Ltd., 39 Moo 4, Klong Udomcholjorn, Muang Chachoengsao, Chachoengsao 24000, Thailand

K-Seri Pharma Sdn Bhd 19 August 2020 till 18 August 2025

POM

2246 BRU20072893P Vitraq Film-coated tablet 75mg

Clopidogrel 75mg (as Clopidogrel Bisulfate)

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 19 August 2020 till 18 August 2025

POM

2247 BRU20072894P Abiratred Abiraterone Acetate Tablets 250mg

Abiraterone Acetate 250mg Dr Reddy’s Laboratories Limited, India

G & H Trading Company 19 August 2020 till 18 August 2025

POM

BDMCA/RMP/1220 Page 167 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2248 BRU20072895P A-Lices Lotion 1% w/w Permethrin 1% w/w HOE Pharmaceuticals Pvt Ltd, Malaysia

G & H Trading Company 19 August 2020 till 18 August 2025

GSL

2249 BRU20072896P Fusidasol cream Each gram contains:Fusidic Acid 2% w/wBetamethasone Dipropionate 0.05% w/w

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 19 August 2020 till 18 August 2025

POM

2250 BRU20072897NP Actimol tablet 500mg Paracetamol 500mg Pharmaniaga Manufacturing Berhad, Malaysia

G & H Trading Company 19 August 2020 till 18 August 2025

GSL: 1 x 10's & 2 x 10's

P: 3 x 10's, 10 x 10's & 100 x 10's

2251 BRU20072898P Proglutrol G2 Sustained Release tablet 2/500mg

Glimepiride 2mg & Metformin Hydrochloride 500mg

Inventia Healthcare Ltd, India Medicorp Sdn Bhd 19 August 2020 till 18 August 2025

POM

2252 BRU20082899P VACODIL TABLETS 6.25MG Carvedilol 6.25 mg Aurobindo Pharma Limited, India K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2253 BRU20082900P Viranz 600 (Efavirenz Tablets USP 600mg)

Efavirenz USP 600mg Aurobindo Pharma Limited, India K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2254 BRU20082901NP Ubat Minyak Geliga Camphor Powder 9.2% w/w; Menthol Crystal 5.51% w/w

Syarikat Wen Ken Drug Sdn Bhd, Malaysia

R. Piee Goodcare Trading 9 December 2020 till 8 December 2025

GSL

2255 BRU20082902P STEGLATRO Film-Coated Tablets 5mg

Ertugliflozin 5mg (as Ertugliflozin L-Pyroglutamic Acid 6.48mg)

Pfizer Manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2256 BRU20082903P STEGLATRO Film-Coated Tablets 15mg

Ertugliflozin 15mg (as Ertugliflozin L-Pyroglutamic Acid 19.43mg)

Pfizer Manufacturing Deutschland GmbH, Germany

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2257 BRU20082904P STEGLUJAN Film-Coated Tablets 5mg/100mg

Ertugliflozin 5mg (as Ertugliflozin L-Pyroglutamic Acid 6.48mg) & Sitagliptin 100mg (as Sitagliptin Phosphate Monohydrate 128.5mg)

Schering-Plough Labo NV, Belgium

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2258 BRU20082905P STEGLUJAN Film-Coated Tablets 15mg/100mg

Ertugliflozin 15mg (as Ertugliflozin L-Pyroglutamic Acid 19.43mg) & Sitagliptin 100mg (as Sitagliptin Phosphate Monohydrate 128.5mg)

Schering-Plough Labo NV, Belgium

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2259 BRU20082906P Erysol for Oral Suspension 200mg/5ml

Erythromycin 200mg/5ml (as Erythromycin Ethylsuccinate)

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 9 December 2020 till 8 December 2025

POM

2260 BRU20082907P Raloxon 60mg Film-Coated Tablets

Raloxifene Hydrochloride 60mg (equivalent to Raloxifene Free Base 56mg)

Pharmathen S.A., Greece Kingsley Medical Supplies Sdn Bhd

9 December 2020 till 8 December 2025

POM

2261 BRU20082908NP Throatsil (Menthol Flavour) i) 2,4-Dichlorobenzyl Alcohol 1.2mgii) Amylmetacresol 0.6mg

Millimed Co. Ltd., Thailand Bintang Ria Sdn Bhd 9 December 2020 till 8 December 2025

GSL

BDMCA/RMP/1220 Page 168 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2262 BRU20082909NP Throatsil (Prune Flavour) i) 2,4-Dichlorobenzyl Alcohol 1.2mgii) Amylmetacresol 0.6mg

Millimed Co. Ltd., Thailand Bintang Ria Sdn Bhd 9 December 2020 till 8 December 2025

GSL

2263 BRU20082910NP Throatsil (Orange Flavour) ) 2,4-Dichlorobenzyl Alcohol 1.2mgii) Amylmetacresol 0.6mgiii) Ascorbic Acid 100mg

Millimed Co. Ltd., Thailand Bintang Ria Sdn Bhd 9 December 2020 till 8 December 2025

GSL

2264 BRU20082911NP Throatsil (Wild Berries Flavour)

i) 2,4-Dichlorobenzyl Alcohol 1.2mgii) Amylmetacresol 0.6mg

Millimed Co. Ltd., Thailand Bintang Ria Sdn Bhd 9 December 2020 till 8 December 2025

GSL

2265 BRU20082912P Univate Cream Clobetasol Propionate 0.05% w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 9 December 2020 till 8 December 2025

POM

2266 BRU20082913P Univate Ointment Clobetasol Propionate 0.05% w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 9 December 2020 till 8 December 2025

POM

2267 BRU20082914P Leflunomide Mevon Film-Coated Tablets 20mg

Leflunomide 20mg Pharmathen S.A., Greece Kingsley Medical Supplies Sdn Bhd

9 December 2020 till 8 December 2025

POM

2268 BRU20082915P Celxib 200 Capsule Celecoxib 200mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2269 BRU20082916P Rexom Salbutamol Elixir 2mg/5ml

Each 5ml contains: Salbutamol Sulphate BP equivalent to Salbutamol BP 2mg/5ml

KCK Pharmaceutical Industries Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2270 BRU20082917P Remafen Enteric-Coated Tablet 50mg

Diclofenac sodium 50mg Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat Bumimedic 9 December 2020 till 8 December 2025

POM

2271 BRU20082918P Peace Syrup Each 5ml contains:Pseudoephedrine Hydrochloride 30mgTriprolidine Hydrochloride 1.25mg

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

BDMCA/RMP/1220 Page 169 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2272 BRU20082919NP ADDAVEN CONCENTRATE FOR SOLUTION FOR INFUSION

1mL of Addaven contains:Chromic chloride hexahydrate 5.33 µgCopper chloride dihydrate 0.10 mgFerric chloride hexahydrate 0.54 mgManganese chloride tetrahydrate 19.8 µgPotassium iodide 16.6 µgSodium fluoride 0.21mgSodium molybdate dehydrate 4.85 µgSodium selenite anhydrous 17.3 µgZinc chloride 1.05 mg

Fresenius Kabi Norge AS, Norway Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2273 BRU20082920P Matenol MR Tablet Trimetazidine Dihydrochloride 35mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2274 BRU20082921P Lamoga-50 Tablet Lamotrigine 50mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2275 BRU20082922P Lamoga-100 Tablet Lamotrigine 100mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2276 BRU20082923P Ultracet Tablet Tramadol Hydrochloride 37.5mg & Paracetamol 325mg

Janssen-Cilag S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2277 BRU20092924NP Dermoplex Calamine Lotion Calamine 6g/100mlZinc Oxide 4g/100ml

Duopharma Manufacturing (Bangi) Sdn Bhd, Malaysia

Bintang Ria Sdn Bhd 9 December 2020 till 8 December 2025

GSL

2278 BRU20092925P Tremfya 100mg/ml Solution for Injection

Guselkumab 100mg/ml Cilag AG, Switzerland Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2279 BRU20092926NP Breacol Expectorant for Adults Guaifenesin 100mg/5ml Pharmaniaga Manufacturing Berhad, Malaysia

Zuellig Pharma (B) Sdn Bh 9 December 2020 till 8 December 2025

GSL

2280 BRU20092927P Skyrizi 75mg Solution for Injection in Pre-Filled Syringe

Risankizumab 75mg/0.83ml Boehringer Ingelheim Pharma G,bH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2281 BRU20092928NP Hydrosil Tablet Dried Aluminium Hydroxide Gel equivalent to Aluminium Hydroxide 200mgMagnesium Hydroxide 200mgSimethicone 20mg

Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Syarikat BumiMedic 9 December 2020 till 8 December 2025

GSL

2282 BRU20092929P Tolmide 500mg Tablet Tolbutamide 500mg Beacons Pharmaceuticals Pte Ltd, Singapore

Hongkiat Trading & Company 9 December 2020 till 8 December 2025

POM

2283 BRU20092930P Edyfil Film Coated Tablet 50mg

Sildenafil Citrate 70.24mg equivalent to Sildenafil 50mg

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

BDMCA/RMP/1220 Page 170 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2284 BRU20092931P Edyfil Film Coated Tablet 100mg

Sildenafil Citrate 140.48mg equivalent to Sildenafil 100mg

Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2285 BRU20092932P Rhinitin Tablet Loratadine 10mg Noripharma Sdn Bhd, Malaysia K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

P

2286 BRU20092933P Bisocor Tablet 2.5mg Bisoprolol Fumarate 2.5mg Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2287 BRU20092934P Bisocor Tablet 5mg Bisoprolol Fumarate 5mg Y.S.P. Industries (M) Sdn Bhd, Malaysia

Asterix United (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2288 BRU20092935P Letara 2.5mg Tablet Letrozole 2.5mg Douglas Manufacturing Ltd, New Zealand

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2289 BRU20102936P HUMIRA Solution For Injection In Pre-Filled Syringe 20mg/0.2ml

Adalimumab 20mg/0.2ml Vetter-Pharma Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2290 BRU20102937P Venclexta Film-Coated Tablets 10mg

Venetoclax 10mg AbbVie Ireland NL B.V., Ireland Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2291 BRU20102938P Venclexta Film-Coated Tablets 50mg

Venetoclax 50mg AbbVie Ireland NL B.V., Ireland Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2292 BRU20102939P Venclexta Film-Coated Tablets 100mg

Venetoclax 100mg AbbVie Ireland NL B.V., Ireland Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2293 BRU20102940P Mementor Tablets 20mg Memantine Hydrochloride 20mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2294 BRU20102941P Menelat 30mg Tablets Mirtazapine 30mg Torrent Pharmaceuticals Ltd., India

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2295 BRU20102942NP Uphalyte Salts Per Sachet Contains:Sodium Chloride 525mgGlucose Anhydrous 6.25gmPotassium Chloride 375mgSodium Bicarbonate 425mg

Duopharma Manufacturing (Bangi) Sdn Bhd, Malaysia

Hongkiat Trading & Company 9 December 2020 till 8 December 2025

GSL

2296 BRU20102943NP Uphalyte Oral Rehydration Salts (Orange)

Per Sachet Contains:Sodium Chloride 525mgDextrose Anhydrous 6.25gmPotassium Chloride 375mgSodium Bicarbonate 425mg

Duopharma Manufacturing (Bangi) Sdn Bhd, Malaysia

Hongkiat Trading & Company 9 December 2020 till 8 December 2025

GSL

2297 BRU20102944P Zytiga 500mg Film-Coated Tablets

Abiraterone Acetate 500mg Patheon France S.A.S., France Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2298 BRU20102945PS1 & BRU20102945PS2

Imfinzi (Durvalumab) Concentrate For Solution For Intravenous Infusion 50mg/ml

Durvalumab 50mg/ml 1) Catalent Indiana, LLC, USA2) Vetter Pharma-Fertigung GmbH & Co. KG, Germany

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

BDMCA/RMP/1220 Page 171 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2299 BRU20102946NP CNI Fire-Sens Mentholated Rub

Methyl Salicylate 22.0% w/wMenthol Crystal 11.5% w/wCamphor 5.0% w/w

Q-Pack (M) Sdn Bhd, Malaysia CNI Enterprise (M) Sdn Bhd 9 December 2020 till 8 December 2025

GSL

2300 BRU20102947NP UTIpure Effervescent Granules Sodium Bicarbonate 1,760mgSodium Citrate anhydrous 630mgCitric acid anhydrous 720mgTartaric acid 890mg

Noripharma Sdn Bhd, Malaysia Kingsley Medical Supplies Sdn Bhd

9 December 2020 till 8 December 2025

GSL

2301 BRU20102948P Defuzin Ointment 2% w/w Sodium Fusidate 2% w/w Xepa-Soul Pattinson (Malaysia) Sdn Bhd, Malaysia

Hongkiat Trading & Company 9 December 2020 till 8 December 2025

POM

2302 BRU20102949P Cotren Vaginal Tablets 100mg Clotrimazole 100mg Biolab Co., Ltd., Thailand Hongkiat Trading & Company 9 December 2020 till 8 December 2025

P

2303 BRU20102950P Paclitaxel 6mg/ml Concentrate For Solution For Infusion

Paclitaxel 6mg/ml Sichuan Huiyu Pharmaceutical Co., Ltd., China

Kingsley Medical Supplies Sdn Bhd

9 December 2020 till 8 December 2025

POM

2304 BRU20102951P Bezartan Tablet 150mg Irbesartan 150mg Duopharma Manufacturing (Bangi) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2305 BRU20102952P Bezartan Tablet 300mg Irbesartan 300mg Duopharma Manufacturing (Bangi) Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2306 BRU20102953NP Rexom Wina Calamine Lotion Calamine BP 6.8% w/vZinc Oxide BP 6.8% w/v

KCK Pharmaceutical Industries Sdn Bhd, Malaysia

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

GSL

2307 BRU20102954P Eberil 60 Film-Coated Tablet Etoricoxib 60mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2308 BRU20102955P Eberil 90 Film-Coated Tablet Etoricoxib 90mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2309 BRU20102956P Eberil 120 Film-Coated Tablet Etoricoxib 120mg Unison Laboratories Co., Ltd., Thailand

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2310 BRU20122957P Salbutamol 100mcg/Actuation HFA Metered Dose Inhaler

Each actuation delivers: Salbutamol Sulphate BP equivalent to Salbutamol 100mcg

Midas Care Pharmaceuticals Pvt. Ltd., India

Kingsley Medical Supplies Sdn Bhd

9 December 2020 till 8 December 2025

POM

2311 BRU20122958NP Panadol Soluble Tablet 500mg Flavour Free

Paracetamol 500mg GlaxoSmithKline Dungarvan Ltd, Ireland

Kingston Beverage & Creamery Sdn Bhd

9 December 2020 till 8 December 2025

GSL - 20’s (5 x 4’s); P - 60’s (15 x 4’s),

120’s (30 x 4’s) Tablets

2312 BRU20122959P Dimax MR 30mg Tablet Gliclazide 30mg Siu Guan Chem Ind. Co. Ltd., Taiwan

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2313 BRU20122960P Imipenem/Cilastin Kabi 500mg/500mg Powder for Solution for Infusion

Imipenem Monohydrate 530mg (equivalent to Imipenem 500mg) Sodium Cilastatin 530mg (equivalent to Cilastatin 500mg)

ACS Dobfar S.p.A., Italy Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

BDMCA/RMP/1220 Page 172 of 173

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BRUNEI DARUSSALAM MEDICINES CONTROL AUTHORITYMINISTRY OF HEALTH, BRUNEI DARUSSALAM

LIST OF REGISTERED MEDICINAL PRODUCTS (UPDATED DECEMBER 2020)

No Product Registration Number

Product Name Active Ingredients Manufacturer Licence Holder Validity of the licence (as of current and until the

end of the validity period as stated)

Product Classification

2314 BRU20122961NP Actal Tablet Sodium Polyhydroxyaluminium Monocarbonate Hexitol Complex 360.0mg equivalent to Aluminium Hydroxide 216.0mg

Pharmaniaga Manufacturing Berhad, Malaysia

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

GSL

2315 BRU20122962P Risperidone Mevon 1mg Tablet

Risperidone 1mg Pharmathen S.A., Greece Kingsley Medical Supplies Sdn Bhd

9 December 2020 till 8 December 2025

POM

2316 BRU20122963P Risperidone Mevon 2mg Tablet

Risperidone 2mg Pharmathen S.A., Greece Kingsley Medical Supplies Sdn Bhd

9 December 2020 till 8 December 2025

POM

2317 BRU20122964P Ator 20mg Film Coated Tablet Atorvastatin 20mg (as Atorvastatin Calcium)

Egyptian International Pharmaceutical Industries Company (EIPICO), Egypt

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2318 BRU20122965P Onsia 4mg Tablet Ondansetron (as Ondansetron Hydrochloride Dihydrate) 4mg

Siam Bheasach Co Ltd., Thailand K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2319 BRU20122966P Piqray 200mg Film Coated Tablet

Alpelisib 200mg Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2320 BRU20122967P Piqray 250mg (200mg+50mg) Film Coated Tablets

Alpelisib 200mg & Alpelisib 50mg Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2321 BRU20122968P Piqray 300mg (150mg+150mg) Film Coated Tablets

Alpelisib 150mg & Alpelisib 150mg Novartis Pharma Stein AG, Switzerland

Zuellig Pharma (B) Sdn Bhd 9 December 2020 till 8 December 2025

POM

2322 BRU20122969P Siagran 50mg Tablet Sumatriptan Succinate equivalent to Sumatriptan 50mg

Siam Bheasach Co Ltd., Thailand K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2323 BRU20122970P Vifas 60mg Tablet Fexofenadine Hydrochloride 60mg Siam Bheasach Co Ltd., Thailand K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

2324 BRU20122971P Intacape Film Coated Tablet 500mg

Capecitabine 500mg Intas Pharmaceuticals Limited, India

Kingsley Medical Supplies Sdn Bhd

9 December 2020 till 8 December 2025

POM

2325 BRU20122972P Intacape Film Coated Tablet 150mg

Capecitabine 150mg Intas Pharmaceuticals Limited, India

Kingsley Medical Supplies Sdn Bhd

9 December 2020 till 8 December 2025

POM

2326 BRU20122973P Calcelar 25 Film Coated Tablet Cinacalcet Hydrochloride equivalent to Cinacalcet 25mg

Unison Laboratories Co. Ltd., Thailand

K-Seri Pharma Sdn Bhd 9 December 2020 till 8 December 2025

POM

BDMCA/RMP/1220 Page 173 of 173