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SPECIAL ISSUE THE KENYA GAZETTE Published by Authority of the Republic of Kenya (Registered as a Newspaper at the G.P.O.) Vol. CXIII—No. 75 NAIROBI, 3rd August, 2011 Price Sh. 50 GAZETTE NOTICE NO. 9237 THE PHARMACY AND POISONS ACT (Cap. 244) THE PHARMACY AND POISONS BOARD PRODUCT EVALUATION AND REGISTRATION DIRECTORATE PRODUCTS REGISTERED FROM JULY TO DECEMBER, 2010 Appl. No. Proposed Reg. No. Trade Name Dosage Form Active Ingredients Market Authorisation Holder Date Of Reg 21645 H2010/21645/454 Esoflux 20mg Capsules Esomeprazole 20mg Acme Laboratories 25th Aug 2010 21644 H2010/21644/455 Esoflux 40mg Capsules Esomeprazole 40mg Acme Laboratories 25th Aug 2010 21646 H2010/21646/456 Hemoproct Suppositories Cinchocaine Hcl Bp 5mg; Hydrocortisone Hcl Bp 5mg; Framycetin Sulphate Bp 10mg; Aesculin 10mg Acme Laboratories 25th Aug 2010 21682 H2010/21682/457 Monas 10 Tablets Montelukast Sodium Inn 10.4mg Equivalent To Montelukast 10mg Acme Laboratories 25th Aug 2010 21680 H2010/21680/458 Nidox Powder Suspension Nitazoxamide 100mg/5mg Acme Laboratories 25th Aug 2010 21647 H2010/21647/459 Nidozox 500mg Tablets Nitazoxanide Inn 500mg Acme Laboratories 25th Aug 2010 19671 H2010/19671/460 Nurifer Capsules Carbonyl Iron Equivalent To Iron 100mg; Folic Acid Bp 1.5mg; Cynocobalamine Bp 15mcg; Ascorbic Acid Bp 75mg; Zinc Sulfate Monohydrate Usp 61.8mg Ajanta Pharma Ltd 25th Aug 2010 21170 H2010/21170/461 Airtical-E Tablets Glucosamine Hcl 647.135mg; Chondroitin Sulphate Sodium 541.565mg Amol Pharmaceuticals Ltd 25th Aug 2010 21169 H2010/21169/462 Amlodip 5mg Tablets Amlodipine Besilate Equivalent To Amlodipine 5mg Amol Pharmaceuticals Ltd 25th Aug 2010 19621 H2010/19621/463 Amrizole Suspension Benzoyl Metronidazole 200mg Equivalent To Metronidazole 125mg Amriya Pharmaceuticals 25th Aug 2010 19620 H2010/19620/464 Ketofan Gel Ketoprofen 2.5gm Amriya Pharmaceuticals 25th Aug 2010 22248 H2010/22248/465 Met-C Gel Metronidazole Bp 1.00% W/W; Chlorhexidine Gluconate Solution Bp Equivalent To Chlorhexidine Gluconate 0.25% W/W Stedman Pharmaceuticals For Armicon Pharmaceuticals Limited 25th Aug 2010 [2953

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Page 1: THE KENYA GAZETTE - Kenya Law Reportskenyalaw.org/kenya_gazette/gazette/download/Vol.CXIII-No_.75_.pdfTHE KENYA GAZETTE Published by ... 19620 H2010/19620/464 Ketofan Gel Ketoprofen

SPECIAL ISSUE

THE KENYA GAZETTE Published by Authority of the Republic of Kenya

(Registered as a Newspaper at the G.P.O.)

Vol. CXIII—No. 75 NAIROBI, 3rd August, 2011 Price Sh. 50

GAZETTE NOTICE NO. 9237

THE PHARMACY AND POISONS ACT

(Cap. 244)

THE PHARMACY AND POISONS BOARD

PRODUCT EVALUATION AND REGISTRATION DIRECTORATE

PRODUCTS REGISTERED FROM JULY TO DECEMBER, 2010

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

21645 H2010/21645/454 Esoflux 20mg Capsules Esomeprazole 20mg Acme Laboratories 25th Aug 2010

21644 H2010/21644/455 Esoflux 40mg Capsules Esomeprazole 40mg Acme Laboratories 25th Aug 2010

21646 H2010/21646/456 Hemoproct Suppositories Cinchocaine Hcl Bp 5mg;

Hydrocortisone Hcl Bp 5mg; Framycetin Sulphate Bp 10mg;

Aesculin 10mg

Acme Laboratories 25th Aug 2010

21682 H2010/21682/457 Monas 10 Tablets Montelukast Sodium Inn 10.4mg

Equivalent To Montelukast 10mg Acme Laboratories 25th Aug 2010

21680 H2010/21680/458 Nidox Powder Suspension Nitazoxamide 100mg/5mg Acme Laboratories 25th Aug 2010

21647 H2010/21647/459 Nidozox 500mg Tablets Nitazoxanide Inn 500mg Acme Laboratories 25th Aug 2010

19671 H2010/19671/460 Nurifer Capsules Carbonyl Iron Equivalent To Iron

100mg; Folic Acid Bp 1.5mg; Cynocobalamine Bp 15mcg; Ascorbic

Acid Bp 75mg; Zinc Sulfate Monohydrate Usp 61.8mg

Ajanta Pharma Ltd 25th Aug 2010

21170 H2010/21170/461 Airtical-E Tablets Glucosamine Hcl 647.135mg;

Chondroitin Sulphate Sodium

541.565mg

Amol Pharmaceuticals

Ltd 25th Aug 2010

21169 H2010/21169/462 Amlodip 5mg Tablets Amlodipine Besilate Equivalent To

Amlodipine 5mg

Amol Pharmaceuticals

Ltd 25th Aug 2010

19621 H2010/19621/463 Amrizole Suspension Benzoyl Metronidazole 200mg

Equivalent To Metronidazole 125mg

Amriya

Pharmaceuticals 25th Aug 2010

19620 H2010/19620/464 Ketofan Gel Ketoprofen 2.5gm Amriya

Pharmaceuticals 25th Aug 2010

22248 H2010/22248/465 Met-C Gel Metronidazole Bp 1.00% W/W; Chlorhexidine Gluconate Solution Bp Equivalent To Chlorhexidine

Gluconate 0.25% W/W

Stedman Pharmaceuticals For Armicon

Pharmaceuticals Limited

25th Aug 2010

[2953

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THE KENYA GAZETTE 3rd August, 2011

2954

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

21827 H2010/21827/466 Asmol Tablets Paracetamol B.P 500mg Astra Lifecare 25th Aug 2010

20450 H2010/20450/467 Water For

Injection Solution Water For Injection Bp B. Braun Melsungen

Ag; Germany For Autosterile Ltd;

Kenya

25th Aug 2010

20686 H2010/20686/468 Histargan 25mg Tablets Promethazine Hcl 25mg Biodeal Laboratories 25th Aug 2010

21003 H2010/21003/469 Azidoc 500mg Tablets Azithromycin Usp 500mg As

Azithromycin Dehydrate

Biodeal Laboratories

Pvt Ltd For Doctor Pharma Uk

25th Aug 2010

22051 H2010/22051/470 Bg-Zole 400 Tablets Albendazole Bp 400mg Bliss Gvs Pharma 25th Aug 2010

20933 H2010/20933/471 Kefrox 125mg/5ml Suspension Cefuroxime Axetil Bp Equivalent To Cefuroxime 250mg

Ccl Pharmaceuticals (Pvt) Ltd; Pakistan

25th Aug 2010

21906 H2010/21906/472 Alerset Tablets Betamethasone Bp 0.25mg;

Dexchlorpheniramine Maleate Bp 2mg

Centaur

Pharmaceuticals Pvt

Ltd For Sai Pharmaceuticals

25th Aug 2010

21902 H2010/21902/473 Lamivudine/Nevir

apine/Zidovudine Tablets Lamivudine 150mg; Neviralpine

200mg; Zidovudine 300mg

Centaur

Pharmaceuticals Pvt Ltd

25th Aug 2010

21429 H2010/21429/474 Amlocip-Nb Tablets Amlodipine 5mg; Nebivolol 5mg Cipla Ltd 25th Aug 2010

16640 H2010/16640/475 Duovir-N Tablets Zidovudine Usp 300mg; Lamivudine Usp 101mg; Nevirapine Usp 200mg

Cipla Ltd 25th Aug 2010

19043 H2010/19043/476 Isotroin-10 Capsules Isotretinoin Usp 10mg Cipla Ltd 25th Aug 2010

19042 H2010/19042/477 Isotroin-20 Capsules Isotretinoin Usp 20mg Cipla Ltd 25th Aug 2010

21432 H2010/21432/478 Lansec Dt Junior Tablets Lansoprazole 15mg Cipla Ltd 25th Aug 2010

21360 H2010/21360/479 Profenac 50mg Tablets Diclofenac Sodium 50mg Cipla Ltd 25th Aug 2010

19916 H2010/19916/480 Curaxone 1g Injection Ceftriaxone Sodium Usp 1gm Claris Lifesciences

Limited 25th Aug 2010

20164 H2010/20164/481 Flucanol Injection Fluconale 200mg Claris Lifesciences

Limited 25th Aug 2010

21797 H2010/21797/482 Microlyse

Disinfectant Solution Benzalkonium Chloride Solution Ip

4% Coral Clinical Systems 25th Aug 2010

21755 H2010/21755/483 Daclobet 15g Cream Clobetasol Propionate Bp 0.05% W/W Dawa Limited 25th Aug 2010

19532 H2010/19532/484 Azo Powder Powder For

Suspension Azithromycin 200mg Delta Pharma Limited 25th Aug 2010

10609 H2010/10609/485 Elymox-500 Capsules Amoxycillin (As Trihydrate) 500mg Elys Chemical Industries Ltd

25th Aug 2010

21311 H2010/21311/486 Etorix 60mg Tablets Etoricoxib 60mg Eskayef Bangladesh 25th Aug 2010

21310 H2010/21310/487 Etorix 90mg Tablets Etoricoxib 90mg Eskayef Bangladesh 25th Aug 2010

21309 H2010/21309/488 Noglog 75mg Tablets Clopidogrel 75mg Eskayef Bangladesh 25th Aug 2010

21943 H2010/21943/489 Julee Hormonal

Contraceptive Tablets Desogestrel Bp 0.15; Ethinyl Estradiol

Usp 0.03mg Famy Care Ltd 25th Aug 2010

21590 H2010/21590/490 Nucleo C.M.P

Forte Capsules Citidine 5 Monophosphate, Disodium

Salt 5mg; Uridine 5 Triphosphate Salt; Uridine 5 Diphosphate Disodium;

Uridine 5 Monophosphate; Disodium Salt

Ferrer International,

S.A 25th Aug 2010

15186 H2010/15186/491 Aziclar 500mg Tablets Clarithromycin Usp 500mg Flamingo

Pharmaceuticals Ltd 25th Aug 2010

18849 H2010/18849/492 Dermavin 500mg Tablets Griseofulvin Bp 500mg Flamingo

Pharmaceuticals Ltd 25th Aug 2010

21199 H2010/21199/493 Bon Hep Tablets Metadoxine 500mg Fourts (India) Labs Ltd

25th Aug 2010

21200 H2010/21200/494 Fourts B Capsules Thiamine Nitrate 12.50mg; Riboflavin

11.50mg; Pyridoxine Hcl 3.45mg;

Nicotinamide 54mg; Acorbic Acid 84.75mg; Zinc Sulfate H2o 55mg;

Chromic Chloride 1.025mg; Sodium Selenite 0.22mg; Sodium Metavanate 0.24mg; Colecalciferol 0.03mg; Acetylcysteine 25.625mg; Glycine

25mg; Glutamic Acid 27mg; Folic Acid 1.3mg

Fourts (India) Labs

Ltd 25th Aug 2010

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3rd August, 2011 THE KENYA GAZETTE 2955

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

15872 H2010/15872/495 Soluvit Novum Injection Biotin 60mcg; Nicotinamide 40mg;

Pyridoxine 4mg; Vitamin B12 5mcg; Vitamin C 100mg; Folic Acid 0.4mg;

Pantothenic Acid 15mg; Thiamine Hydrochloride 3.2mg; Vitamin B2

3.6mg

Fresenius Kabi Ab 25th Aug 2010

21607 H2010/21607/496 Epirubicina 50mg Injection Epirubicina Clorhidrato 50mg; Lactosa Monohidrato 250mg

Glenmark Pharmaceuticals

25th Aug 2010

20787 H2010/20787/497 Potassium

Chloride Injection Potassium Chloride Bp 100mg Harson Laboratories

Ltd; India 25th Aug 2010

20446 H2010/20446/498 Sodium

Bicarbonate Injection Sodium Bicarbonate Bp 8.4% W/V Harson Laboratories

Ltd; India 25th Aug 2010

21597 H2010/21597/499 Febricet C Tablets Paracetamol 330mg; Vitamin C 200mg Hemofarm 25th Aug 2010

21598 H2010/21598/500 Febricet Cold Sachet Paracetamol 500mg; Vitamin C

200mg; Pheniramine Maleate 25mg Hemofarm 25th Aug 2010

21903 H2010/21903/501 Flamar-Mx Tablets Paracetamol Bp 325mg;

Chlorzoxazone Usp 250mg; Diclofenac Potassium Bp 50mg

Indoco Remedies 25th Aug 2010

21019 H2010/21019/502 Doverin Injection Drotaverin 20mg/Ml Intas Pharmaceuticals

Ltd 25th Aug 2010

21952 H2010/21952/503 Cardoz-12.5 Tablets Carvedilol 12.5mg Ipca Laboratories Ltd 25th Aug 2010

21951 H2010/21951/504 Cardoz-25 Capsules Carvedilol Ep 25mg Ipca Laboratories Ltd 25th Aug 2010

21957 H2010/21957/505 Clopact-75 Tablets Clopidogrel Bisulfate Usp Ipca Laboratories Ltd 25th Aug 2010

21293 H2010/21293/506 Hexigel Oral Gel Chlorhexidine Gluconate Solution5.639% W/W

Ipca Laboratories Ltd 25th Aug 2010

21295 H2010/21295/507 Mucopain Oral Gel Benzocaine 20% W/W Ipca Laboratories Ltd 25th Aug 2010

20625 H2010/20625/508 Kinem 1000mg Injection Imipenem Usp 500mg; Cilastatin 500mg

Kilitch Drugs Ltd 25th Aug 2010

20623 H2010/20623/509 K-Penem 1000mg Injection Meropenem Usp 1g Kilitch Drugs Ltd 25th Aug 2010

19867 H2010/19867/510 Eritrogen 2000 Iv Injection Erythropoetin 2000 Iu Laboratorios Bago S.A 25th Aug 2010

19738 H2010/19738/511 Infa-V Ointment Metronidazole Bp 10%; Clotrimazole

Bp 2% Lark Labs Ltd; India 25th Aug 2010

21314 H2010/21314/512 Accuzon 250 Usp Injection Ceftriaxone Anhydrous 250mg Macleods Pharmaceuticals

25th Aug 2010

21676 H2010/21676/513 Provir Injection Sterile, Freeze-Dried Acyclovir As The

Sodium Salt 250mg

Curon For Makupa

Chemist 25th Aug 2010

20254 H2010/20254/514 Starpram 10mg Tablets Escitalopram 10mg Maple Pharma 25th Aug 2010

20602 H2010/20602/515 Tenofovir

Disoproxil

Fumarate/Efavirenz/Emtricitabine

Tablets Tenofovir Disoproxil Fumarate

300mg; Efavirenz 600mg;

Emtricitabine 200mg

Matrix Laboratories

Limited (A Subsidiary

Of Mylan Laboratories

25th Aug 2010

21642 H2010/21642/516 Flubiotic Dry Syrup Flucloxacillin B.P 125mg/5ml Maxim

Pharmaceuticals Ltd Manuf. By Navana

Pharmaceuticals

25th Aug 2010

21641 H2010/21641/517 Revam Kids Syrup Vitamin A Bp 2000iu; Vitamin D Bp

200iu; Vitamin C Bp 17.5mg; Vitamin B1 Bp 0.70mg; Vitamin B2 Bp

0.85mg; Vitamin6 Bp 0.35mg; Vitamin E Bp 0.35mg; Nicotinamide

Bp 9.0mg; Cod Liver Oil 100mg

Maxim

Pharmaceuticals Ltd Manuf. By Navana

Pharmaceuticals

25th Aug 2010

21580 H2010/21580/518 Paracetamol 500mg

Tablets Paracetamol 500mg Medisel (K) Ltd 25th Aug 2010

20462 H2010/20462/519 Medomox 250 Suspension Amoxicillin Trihydrate Bp 250mg Medopharm Pvt Ltd 25th Aug 2010

17990 H2010/17990/520 Euril 10mg Tablets Enalapril Maleate 10mg Medreich Plc 25th Aug 2010

17989 H2010/17989/521 Euril 5mg Tablets Enalapril Maleate 5mg Medreich Plc 25th Aug 2010

21298 H2010/21298/522 Omizec 40mg Injection Omeprazole 40mg Medreich Plc 25th Aug 2010

22094 H2010/22094/523 Glucophage Xr

500mg Tablets Metformin Chloride 500mg Merck South Africa 25th Aug 2010

22095 H2010/22095/524 Glucophage Xr

750mg Tablets Metformin Chloride 750mg Merck South Africa 25th Aug 2010

21774 H2010/21774/525 Gynosporin Cream Clotrimazole Usp 20g Nabiqasim Industries 25th Aug 2010

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THE KENYA GAZETTE 3rd August, 2011

2956

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

Vaginal (Pvt) Ltd

21243 H2010/21243/526 Naprotax

260mg/45ml Injection Paclitaxel 6mg Naprod Life Sciences 25th Aug 2010

21083 H2010/21083/527 Naxiprazol 20 Capsules Esomeprazole 20mg National Company For Pharmaceutical

Industry

25th Aug 2010

21082 H2010/21082/528 Naxiprazol 40 Capsules Esomeprazole 40mg National Company

For Pharmaceutical Industry

25th Aug 2010

21613 H2010/21613/529 Prostatin 0.4mg Capsules Tamulosin Hcl 0.4mg National Company

For Pharmaceutical Industry

25th Aug 2010

21057 H2010/21057/530 Apetimax Syrup Cyproheptadine Hcl Bp 2mg Neomedic Llc 25th Aug 2010

21600 H2010/21600/531 Lox Heavy 5% Injection Lidocaine Hydrochloride Usp 53.3mg; Dextrose Usp 75.0mg

Neon Laboratories Ltd 25th Aug 2010

21945 H2010/21945/532 Sucol Injection Suxamethonium Chloride Neon Laboratories Ltd 25th Aug 2010

20175 H2010/20175/533 Mazit 200mg/5ml Suspension Azithromycin Dihydrate Equivalent To Azithromcyin Ph.Eur/ 200mg

Neopharma; Uae 25th Aug 2010

20919 H2010/20919/534 Bactrid 228.5 Suspension Amoxicillin Trihydrate Usp

Equivalent To Amoxicillin 200mg;

Clavulanate Potassium Usp Equivalent To Clavulanic Acid 28.5mg

Nexgen Healthcare 25th Aug 2010

21488 H2010/21488/535 Nirpid 20% Injection Soybean Oil Usp 20.00g; Egg Lecithin

1.20g; Glycerol Bp 2.25mg Nirlife 25th Aug 2010

21638 H2010/21638/536 Sterilised Water

For Injection Injection Sterilized Water For Injection Bp Nirma Ltd 25th Aug 2010

21441 H2010/21441/537 Exforge Hct 10mg/160mg/12.5

mg

Tablets Amlodipine 10mg; Valsartan 160mg; Hydrochlorothiazide 12.5mg

Novartis Pharma Stein Ag

25th Aug 2010

21440 H2010/21440/538 Exforge Hct

5mg/160mg/12.5mg

Tablets Amlodipine 5mg; Valsartan 160mg;

Hydrochlorothiazide 12.5mg

Novartis Pharma

Stein Ag 25th Aug 2010

21677 H2010/21677/539 Galvus Met

50/500mg Tablets Vildagliptin; Metformin Hcl Novartis Pharma

Stein Ag 25th Aug 2010

21678 H2010/21678/540 Galvus Met

50/850mg Tablets Vildagliptin; Metformin Hcl Novartis Pharma

Stein Ag 25th Aug 2010

21679 H2010/21679/541 Galvusmet Tablets Vildagliptin; Metformin50mg/1000mg Novartis Pharma Stein Ag

25th Aug 2010

21710 H2010/21710/542 Ondavell 8mg Tablets Ondansetron Hcl 8mg Novell 25th Aug 2010

22149 H2010/22149/543 Eclamsil 5ml Injection Magnesium Sulphate 500mg Opsonin Pharma 25th Aug 2010

21443 H2010/21443/544 Paracetamol Syrup Paracetamol 120mg Orbit Consumer

Products 25th Aug 2010

21501 H2010/21501/545 Pangraf 0.5mg Capsules Tacrolimus 0.5mg Panacea Biotech 25th Aug 2010

21499 H2010/21499/546 Pangraf 1.0mg Capsules Tacrolimus 1mg Panacea Biotech 25th Aug 2010

21500 H2010/21500/547 Pangraf 5.0mg Capsules Tacrolimus 5mg Panacea Biotech 25th Aug 2010

22202 H2010/22202/548 Clinica

Mouthwash Liquid Chlorhexidine Gluconate 0.2% W/V Platinum

Pharmaceuticals (Pvt) 25th Aug 2010

22205 H2010/22205/549 Enziclor Mouth

Wash Liquid Benzydamine Hydrochloride (B.P)

0.15% W/V; Chlorhexidine Gluconate (B.P) 0.2% W/V

Platinum

Pharmaceuticals (Pvt) 25th Aug 2010

17277 H2010/17277/550 Lipix 20mg Tablets Simvastatin Usp 20mg Platinum

Pharmaceuticals (Pvt) 25th Aug 2010

22204 H2010/22204/551 Prodent Mouth

Wash Liquid Potassium Nitrate (Bp) 1% W/V Platinum

Pharmaceuticals (Pvt) 25th Aug 2010

19953 H2010/19953/552 Aminogro Capsules L-Isoleucine Usp 100mg; L-Leucine

Usp 125mg; L-Valine Usp 75mg; L-Lysine Hcl Usp 150mg; L-Methionine

Usp 25mg; L-Threonine Usp 25mg; L-Phenylalanine Usp 50mg;L-Tryptophan Usp 5mg; L-Proline Usp 25mg; L-Glutamine Usp 150mg; L-

Arginine Usp 100mg; Thiamine Hcl Bp 5mg; Riboflavin 5mg; Pyridoxine

Hcl 1.5mg; Folic Acid Bp 0.5mg;

Prisma

Pharmaceuticals Ltd 25th Aug 2010

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3rd August, 2011 THE KENYA GAZETTE 2957

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

Cyanocobalamine 5µG

21805 H2010/21805/553 Alburel 100ml Sodium Caprylate 6.65g/L Reliance Life Sciences 25th Aug 2010

21807 H2010/21807/554 Reliferon 3 Miu Injection R-Human Interferon Alpha 2b

Injection 3miu Reliance Life Sciences 25th Aug 2010

21806 H2010/21806/555 Reliferon 5 Miu Injection R-Human Interferon Alpha 2b

Injection 5miu Reliance Life Sciences 25th Aug 2010

21802 H2010/21802/556 Religrast 300mcg Solution 300mcg Of Filgrastim Concentrated Solution Ph. Eur. (Rhg-Csf) In

Acqueous Buffer

Reliance Life Sciences 25th Aug 2010

21886 H2010/21886/557 Relipoietin

4,000iu Injection Erythropoetin Concentrated Solution

Ph. Eur. 4,000iu Reliance Life Sciences 25th Aug 2010

19945 H2010/19945/558 Glucantime Injection Meglumine Antimoniate 1.5g Sanofi Aventis 25th Aug 2010

20795 H2010/20795/559 Aerinaze

2.5mg/120mg Tablets Desloratidine 2.5mg; Pseudoephedrine

120mg

Schering Plough;

Blegium 25th Aug 2010

19954 H2010/19954/560 Ximacef 100 Oral Suspension Cefixime 100mg Sigma Pharmaceuticals

25th Aug 2010

19955 H2010/19955/561 Ximacef 400mg Capsules Cefixime 400mg Sigma

Pharmaceuticals 25th Aug 2010

22093 H2010/22093/562 Hefimar Capsules Flunarizine Dihydrochloride Bp Stedman

Pharmaceuticals 25th Aug 2010

20518 H2010/20518/563 Hepa Injection Heparin Sodium Bp 5000iu (Derived

From Mucosa)

Swiss Parenterals Ltd;

India 25th Aug 2010

18765 H2010/18765/564 Cefty 400mg Tablets Cefixime Usp As Trihydtrate Equivalent To Anhydrous Cefixime

400mg

Swiss Pharma 25th Aug 2010

21980 H2010/21980/565 Telmikaa 80 Tablets Telmisartan Bp 80mg Troikaa

Pharmaceuticals Ltd 25th Aug 2010

20184 H2010/20184/566 Clarimet 500mg Tablets Clarithromycin Usp 500mg Unicure Remedies; India For Metro

Pharmaceuticals Ltd

25th Aug 2010

21556 H2010/21556/567 Dospa 125mg Tablets Mebeverine Hcl 125mg Universal Corporation

Ltd; Kenya 25th Aug 2010

20227 H2010/20227/568 Isonide 150mg Tablets Isoniazid Bp 150mg Universal Corporation Ltd; Kenya

25th Aug 2010

21475 H2010/21475/569 Lamozid Kid Tablets Lamivudine 30mg; Zidovudine 60mg Universal Corporation

Ltd; Kenya 25th Aug 2010

20491 H2010/20491/570 Nelquin Peadiatric

Drops

Peadiatric

Drops Quinine Dihydrochloride Bp 20% W/V Universal Corporation

Ltd; Kenya 25th Aug 2010

19887 H2010/19887/571 Citabol 200mg Injection Gemcitabine Hydrochloride Usp

Equivalent To Gemcitabine 200mg Venus Remedies Ltd 25th Aug 2010

19894 H2010/19894/572 Platol 50mg/100ml Injection Cisplatin 0.5mg Venus Remedies Ltd 25th Aug 2010

20766 H2010/20766/573 Jointcare Nsm Tablets Docosahexaenoic Acid 300mg;

Eicosapentaenoic Acid 60mg; Methyl Sulphonyl Methane 250mg;

Glucsamine Sulphate Kcl 500mg; Chondroitin Sulphate 50mg; Vitamin

D3 10mcg; Folic Acid 200mcg; Vitamin B12 10mcg; Zinc 5mg; Copper

0.5mg; Manganese 2mg; Selenium 60mcg; Ginger Root Extract

Equivalent To 40mg; Rose Hip 50mg

Vitabiotics Ltd 25th Aug 2010

20765 H2010/20765/574 Pregnacare Tablets Plus

Omega-3

Vitamin E 20mg; Vitamin D3 10mcg; Vitamin C 70mg; Vitamin B1 3mg;

Vitamin B2 2mg; Vitamin B3 20mg;Folic Acid 400mcg; Vitamin B12

6mcg; Biotin 150mg Pantothenic Acid 6mg; Vitamin K 70mcg; Natural

Mixed Carotenoids 2mg; Iron 17mg; Magnesium 150mg; Zinc 15mg; Iodine

140mcg; Copper 1000mcg; Selenium 30mcg; Docosahexaenoic Acid 300mg;

Eicosapentaenoic Acid 60mg

Vitabiotics Ltd 25th Aug 2010

21505 H2010/21505/575 Urgendol P Tablets Tramadol Hydrochloride Bp 37.5mg;

Paracetamol 325mg Win-Medicare Pvt 25th Aug 2010

21865 H2010/21865/576 Paragen Tablets Paracetamol 500mg Xier Kangtai 25th Aug 2010

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THE KENYA GAZETTE 3rd August, 2011

2958

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

Paracetamol

21354 H2010/21354/577 Econazine Cream Econazole Nitrate 10mg;

Traimcinolone Acetate 1mg

Y.S.P Industries;

Malaysia 25th Aug 2010

21355 H2010/21355/578 Voren Plus Topical

Topical Gel Diclofenac Sodium 50mg Y.S.P Industries; Malaysia

25th Aug 2010

21866 H2010/21866/579 Acenquine I.M/I.V Injection Heparin Sodium Bp 5000iu (Derived

From Mucosa), Benzyl Alcohol Bp

0.95% W/V (As Preservative)

Yanzhou Xier

Kangtai

Pharmaceutical Co. Ltd; China

25th Aug 2010

20724 H2010/20724/580 Recophen Suspension Chloranphenicol 125mg Zest Pharma 25th Aug 2010

20730 H2010/20730/581 Throcin Suspension Erythromycin Stearate Bp Equivalent

To Erythromycin 200mg Zest Pharma 25th Aug 2010

21571 H2010/21571/582 Amosun 125mg Oral Granules Amoxicillin (As Trihydrate) 125mg Zhuhai United Labs

(Zhongshan) Co. Ltd 25th Aug 2010

22023 H2010/22023/583 Mdp-250 Tablets Methyldopa Usp 250mg Innocia Lifesciences 25th Aug 2010

21422 H2010/21422/584 Glucose 5% Iv Injection Glucose 5% W/V Abacus Parenterals

Drugs Ltd 25th Aug 2010

21423 H2010/21423/585 Sodium Lactate Iv Injection Sodium Lactate 0.320gm Abacus Parenterals

Drugs Ltd 25th Aug 2010

21424 H2010/21424/586 Water For Injection

Injection Water For Injection Abacus Parenterals Drugs Ltd

25th Aug 2010

21421 H2010/21421/587 Sodium Chloride

Iv Injection Sodium Chloride 0.9% W/V Abacus Parenterals

Drugs Ltd 25th Aug 2010

20056 H2010/20056/588 Kamagra Oral

Jelly Jelly Kamagra Oral Jelly 100mg; Sildenafil

Oral Jelly 100mg/5g Ajanta Pharma Ltd 25th Aug 2010

21168 H2010/21168/589 Diaboric 500mg Tablets Ornidazole 500mg Amol Pharmaceuticals

Ltd 25th Aug 2010

20264 H2010/20264/590 Flagyl 500mg Pessaries Metronidazole 500mg Aventis 25th Aug 2010

21570 H2010/21570/591 Canem-0 Tablets Feropenem Sodium 200mg Cachet

Pharmaceuticals 25th Aug 2010

19680 H2010/19680/592 Terbisil Antifungal

Spray Terbinafine Hydrochloride 1% W/W Cipla Ltd 25th Aug 2010

20830 H2010/20830/593 Lycogold Capsules Lycophen 5000mcg; Vitamin A Bp

2500iu; Vitamin E Bp 10iu; Ascorbi

Acid Bp 50mg; Selenium Dioxide 70mcg; Zinc Sulphate 27.45mg

Corona Remedies 25th Aug 2010

20763 H2010/20763/594 Gemita Injection Gemcitabine Hcl 1g Dabur Pharma 25th Aug 2010

21015 H2010/21015/595 Efrodol Tablets Acetaminophen 500mg; Pyrilamine

Maleate 75mg

Efroze Chemical

Industries 25th Aug 2010

20547 H2010/20547/596 Atazor 300mg Capsules Atazanavir Sulfate Equivalent To

Atazanavir 300mg

Emcure

Pharmaceuticals Ltd 25th Aug 2010

22191 H2010/22191/597 L Montus Tablets Levocetirizine Hydrochloride 5mg;

Montelukast Sodium Equivalent To Montelukast 10mg

Fourrts Laboratories

Pvt Ltd 25th Aug 2010

21748 H2010/21748/598 Rejunuron Capsules Alpha Lipoic Acid 100mcg;

Methylcobalamin 500mcg

Fourrts Laboratories

Pvt Ltd 25th Aug 2010

21578 H2010/21578/599 Ranitidine Tablets Ranitidine Hcl 300mg Gracure

Pharmaceuticals 25th Aug 2010

22257 H2010/22257/600 Le Nadin-180 Tablets Fexofenadine Hydrochloride 180mg Gracure Pharmaceuticals

25th Aug 2010

22258 H2010/22258/601 Le Nadin-120 Tablets Fexofenadine Hydrochloride 120mg Gracure

Pharmaceuticals 25th Aug 2010

21724 H2010/21724/602 Magnesium

Sulphate Injection Magensium Sulphate I.P 500mg(50%

W/V); Water For Injection I.P Q.S Harson Laboratories 25th Aug 2010

20350 H2010/20350/603 Fendol D.S. Tablets Mefenamic Acid Bp 500mg Hikma

Pharmaceuticals Ltd 25th Aug 2010

21108 H2010/21108/604 Hemsyl-500mg Tablets Ethamsylate Bp 500mg Indoco Remedies Ltd 25th Aug 2010

21603 H2010/21603/605 Hemsyl Injection Ethamsylate Bp125mg Indoco Remedies Ltd 25th Aug 2010

22209 H2010/22209/606 Teltas-40 H Tablets Telmisartan Ph Eur 40mg;

Hydrochlorthiazide 12.5mg Intas Pharmaceuticals 25th Aug 2010

22210 H2010/22210/607 Teltas-80 H Tablets Telmisartan Ph Eur 80mg; Intas Pharmaceuticals 25th Aug 2010

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No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

Hydrochlorthiazide 25mg

22184 H2010/22184/608 Nebtas-H Tablets Nebivolol Hydrochloride Equivalent

To Nebivolol 5mg; Hydrochlorthiazide 12.5mg

Intas Pharmaceuticals 25th Aug 2010

20741 H2010/20741/609 Rapid Relief Hot

Gel Gel Menthol 5.91% W/W; Eucalyptus Oil

1.97% W/W; Methyl Salicylate 12.80% W/W; Turpentine Oil 1.47%

W/W

L'amar For Cipla Ltd;

India 25th Aug 2010

22101 H2010/22101/610 Ibuprofen 200mg Tablets Ibuprofen Bp 200mg Macleods

Pharmaceuticals 25th Aug 2010

22100 H2010/22100/611 Carbamazepine Tablets Carbamazepine Bp 200mg Macleods Pharmaceuticals

25th Aug 2010

21897 H2010/21897/612 Ciprofloxacin

500mg Tablets Ciprofloxacin Hydrochloride Usp

Equivalent To Ciprofloxacin 500mg

Macleods

Pharmaceuticals 25th Aug 2010

22001 H2010/22001/613 Omemark 40mg Injection Omeprazole Sodium Bp Equivalent To

Omeprazole 40mg Marksans Pharma Ltd 25th Aug 2010

22003 H2010/22003/614 Izole 100mg Capsules Itraconazole 100mg Marksans Pharma Ltd 25th Aug 2010

21812 H2010/21812/615 Myostigmin Injection Neostigmine 0.5mg/Ml Neon Laboratories Ltd 25th Aug 2010

21511 H2010/21511/616 Thiosol

(Thiopental

Sodium)

Injection Thiapental Sodium Bp 1g Neon Laboratories Ltd 25th Aug 2010

21512 H2010/21512/617 Thiosol 500mg Injection Thiopental Sodium Bp 500mg Neon Laboratories Ltd 25th Aug 2010

21486 H2010/21486/618 Nirmin 5-S Injection Amino Acids 5%; Sorbitol 5% Nirlife Healthcare;

India 25th Aug 2010

21072 H2010/21076/619 Pantoloc 20mg Tablets Pantoprazole 20mg Nycomed Pty 25th Aug 2010

21076 H2010/21076/620 Pantoloc 40mg Tablets Pantoprazole 40mg Nycomed Pty 25th Aug 2010

21134 H2010/21134/621 Rhogam Ultra

Filtered Plus 300mcg

Injection Human Immunoglobulin 300mcg Ortho Clinical

Diagnostics 25th Aug 2010

21555 H2010/21555/622 Aricept 10mg Tablets Donepezil Hcl 10mg Pfizer Laboratories 25th Aug 2010

17278 H2010/17278/623 Alfa-D Drops Drops Alfacelcidol 2mcg Platinum Pharmaceuticals

25th Aug 2010

21588 H2010/21588/624 Malacur 4-/320 Tablets Dihydroartemisinin 40mg;

Piperaquine Phosphate 320mg Salvat Laboratories 25th Aug 2010

18340 H2010/18340/625 Haemo Forte Iron

Tonic Ferric Ammonium Citrate Bp 1000mg;

Folic Acid Bp 11mg; Pyridoxine Hcl Bp 48mg; Thiamine Hcl Bp 24mg;

Nicotinamide Bp 220mg

Pliva Pakistan Pvt

Ltd For Royal Group 25th Aug 2010

21609 H2010/21609/626 Misoclear 200mcg Tablets Misoprostol 200mcg Sigma

Pharmaceuticals Ltd 25th Aug 2010

21524 H2010/21524/627 Tizigesic 4mg Tablets Tizanidine 4mg Unichem Laboratories 25th Aug 2010

20486 H2010/20486/628 Vital-Z Sachets Powder Anhydrous Glucose Bp 17.5g; Sucrose

Bp 14gm; Zinc Sulphate Heptahydrate Bp Equivalent

Elemental Zinc 7.5mg; Ascorbic Acid 50mg

Unicure Remedies Ltd 25th Aug 2010

21489 H2010/21849/629 Aciphin 250mg Im Injection Ceftriaxone 250mg As Sodium U.S.P Aci Limited 4th Nov. 2010

21490 H2010/21490/630 Aciphin 500mg Im Injection Ceftriaxone 500mg As Sodium U.S.P Aci Limited 4th Nov. 2010

21491 H2010/21491/631 Aciphin 1g Iv Injection Ceftriaxone 1g As Sodium U.S.P Aci Limited 4th Nov. 2010

21492 H2010/21492/632 Kacin 500 Im/Iv Injection Amikacin 500mg As Sulfate U.S.P Aci Limited 4th Nov. 2010

21493 H2010/21493/633 Kacin 100 Im/Iv Injection Amikacin 100mg As Sulfate U.S.P Aci Limited 4th Nov. 2010

21494 H2010/21494/634 Cerox-A 250 Tablets Cefuroxime 250mg As Axetil U.S.P Aci Limited 4th Nov. 2010

22190 H2010/22190/635 Diclofen 100mg Tablets Diclofenac 100mg Aglowmed Limited 4th Nov. 2010

19777 H2010/19777/636 Agophenol Capsules Chloramphenicol Bp 250mg Agog Pharma Ltd 4th Nov. 2010

21322 H2010/21322/637 Fluphenazine

25mg/Ml Injection Fluphenazine Decanoate 25mg Ambalal Sarabhai

Enterprises Ltd 4th Nov. 2010

19126 H2010/19126/638 Alphachymotrypsin

Injection Alpha Chymotrypsin 5mg Amoun Pharmaceuticals Co

4th Nov. 2010

20857 H2010/20857/639 Aurotaz-P 4.5g I Injection Piperacillin 4g; Tazobactam 0.5g Aurobindo Pharma Limited

4th Nov. 2010

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2960

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

14573 H2010/14573/640 Drox 500 Capsules Cefadroxil As Monohydrate 500mg Aurobindo Pharma

Limited 4th Nov. 2010

21521 H2010/21521/641 Digoxin 0.25mg Tablets Digoxin 0.25mg Aurochem Laboratories

4th Nov. 2010

21872 H2010/21872/642 Aurocol-Dm Chloramphenicol Bp 0.5% W/V;

Dexamethasone Sodium Phosphate

Bp 0.1% W/V; Phenyl Mercuric Nitrate Usp 0.002% W/V

Aurolab 4th Nov. 2010

21871 H2010/21871/643 Aurozole Econazole 2% W/V; Chlorbutol Usp

0.5% W/V; Arachis Oil B.P Qs Aurolab 4th Nov. 2010

18020 H2010/18020/644 Coro-Intro Pump Spray Glyceryl Trinitrate 0.4mg Ayrton Saunders 4th Nov. 2010

21143 H2010/21143/645 Rinatadin 150mg Tablets Ranitidine Hcl 150mg Bal Pharma Ltd 4th Nov. 2010

21140 H2010/21140/646 Ibuprofen 400mg Tablets Ibuprofen 400mg Bal Pharma Ltd 4th Nov. 2010

21456 H2010/21456/647 Rhoclone 300mcg Injection Monoclonal Anti Rho-D Immunoglobulin 300mcg

Bharat Serums And Vaccines Ltd

4th Nov. 2010

21777 H2010/21777/648 Acinet Dry Syrup Amoxicillin 125mg; Clavulanic Acid

31.25mg

Cachet

Pharmaceuticals Ltd 4th Nov. 2010

21815 H2010/21815/649 Noclot 75mg Tablets Clopidogrel Hydrogen Sulphate Usp

Equivalent To Clopidogrel 75mg

Ccl Pharmaceuticals

(Pvt) Ltd 4th Nov. 2010

20739 H2010/20739/650 Valtec 200mg Tablets Sodium Valproate Bp 200mg; Valproic

Acid Usp 87mg Cipla Ltd 4th Nov. 2010

21537 H2010/21537/651 Tna-Peri Injection Amino Acids Claris Life Sciences Ltd

4th Nov. 2010

21671 H2010/21671/652 Lactone 100mg Tablets Spironolactone 100mg Cspc Group Co. Ltd;

China For Medisel (K)

Ltd

4th Nov. 2010

21672 H2010/21672/653 Lactone 25mg Tablets Spironolactone 25mg Cspc Group Co. Ltd; China For Medisel (K)

Ltd

4th Nov. 2010

21673 H2010/21673/654 Chlorpromazine

100mg Tablets Chlorpromazine 100mg Cspc Group Co. Ltd;

China For Medisel (K) Ltd

4th Nov. 2010

21329 H2010/21329/655 Dawaclox 250mg Capsules Cloxacillin 250mg Dawa Ltd 4th Nov. 2010

21188 H2010/21188/656 Topquine Mixture Quinine Dihydrochloride 61.24mg/5ml Dawa Ltd 4th Nov. 2010

19909 H2010/19909/657 Dawanol Syrup Paracetamol Bp 120mg Dawa Ltd 4th Nov. 2010

19754 H2010/19754/658 Lum-Artem Tablets Artemether 20mg; Lumefantrine

120mg Dawa Ltd 4th Nov. 2010

21520 H2010/21520/659 Mefpar Tablets Mefenamic Acid 250mg; Paracetamol 500mg

Dawa Ltd 4th Nov. 2010

19527 H2010/19527/660 Staxim

125mg/5mg Suspension Cefuroxime 125mg Delta Pharma Ltd 4th Nov. 2010

19531 H2010/19531/661 Azo 500 Tablets Azithromycin 500mg Delta Pharma Ltd 4th Nov. 2010

22071 H2010/22071/662 Bio-Met 500 Tablets Metformin Hydrochloride Bp 500mg Devang

Pharmaceuticals Pvt

Ltd

4th Nov. 2010

22072 H2010/22072/663 Bio-Met 850 Tablets Metformin Hydrochloride Bp 850mg Devang Pharmaceuticals Pvt

Ltd

4th Nov. 2010

21319 H2010/21319/664 Levohista Tablets Cerotezine 5mg Devang

Pharmaceuticals Pvt Ltd

4th Nov. 2010

21321 H2010/21321/665 Aceclodeal 100mg Tablets Aceclogenac 100mg Devang

Pharmaceuticals Pvt Ltd

4th Nov. 2010

21631 H2010/21631/666 Miconal 2%

Topical Cream Miconazole 20gm Ecobi Farmaceuticals 4th Nov. 2010

21632 H2010/21632/667 Miconal 2%

Topical Powder Miconazole 20gm Ecobi Farmaceuticas 4th Nov. 2010

21633 H2010/21633/668 Miconal 2% Vaginal

Lavage Miconazole 200gm Ecobi Farmaceuticals 4th Nov. 2010

22160 H2010/22160/669 Kanzar H 50mg Tablets Losartan Potassium 50mg; Hydrochlorthiazde 12.5mg

Hikma Pharma S.A.E. 4th Nov. 2010

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Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

22161 H2010/22161/670 Glucoryl 2mg Tablets Glimepiride 2mg Hikma Pharma S.A.E. 4th Nov. 2010

22159 H2010/22159/671 Kanzar H 100mg Tablets Losartan Potassium 100mg;

Hydrochlorthiazide 25mg Hikma Pharma S.A.E. 4th Nov. 2010

22158 H2010/22158/672 Alkapress 10mg Tablets Amlodipine 10mg Hikma Pharma S.A.E. 4th Nov. 2010

22157 H2010/22157/673 Alkapress 5mg Tablets Amlodipine 5mg Hikma Pharma S.A.E. 4th Nov. 2010

21688 H2010/21688/674 Desodin Syrup Desloratadine Inn 2.5mg Eskayef Bangladesh

Ltd 4th Nov. 2010

12988 H2010/12988/675 Tikocin 300mg Capsules Rifampicin Bp 300mg Flamingo

Pharmaceuticals 4th Nov. 2010

21975 H2010/21975/676 Dermosone 30g Cream Betamethasone Dipropionate Cream

Usp 0.05%

Galentic Pharma

(India) Pvt Ltd 4th Nov. 2010

21757 H2010/21757/677 Aphrodis-100 Tablets Sildenafil Citrate 100mg Galpha Laboratories Ltd

4th Nov. 2010

20721 H2010/20721/678 Xmet 500 Tablets Metformin Hydrochloride Bp 500mg Glenmark

Pharmaceuticals 4th Nov. 2010

20722 H2010/20722/679 Xmet 850 Tablets Metformin Hydrochloride Bp 850mg Glenmark

Pharmaceuticals 4th Nov. 2010

20165 H2010/20165/680 Amroxol-S Syrup Ambroxol Hydrochloride B.P 15mg;

Sulbutamol Sulphate B.P 1.205mg

Gracure

Pharmaceuticals 4th Nov. 2010

20114 H2010/20114/681 Piozone-30 Tablets Pioglitazone Hydrochloride Equivalent To Pioglitazone 30mg

Gracure Pharmaceuticals

4th Nov. 2010

20115 H2010/20115/682 Piozone-15 Tablets Pioglitazone Hydrochloride

Equivalent To Pioglitazone 15mg

Gracure

Pharmaceuticals 4th Nov. 2010

20966 H2010/20966/683 Cefaclor-250 Capsules Cefaclor Usp Equivalent To

Anhydrous Cefaclor 250mg

Gracure

Pharmaceuticals 4th Nov. 2010

20936 H2010/20936/684 Aminophylline Injection Aminophylline Bp 250mg Harsons Laboratories 4th Nov. 2010

20935 H2010/20935/685 Atracurium

Besylate Injection Atracurium Besylate Usp 10mg Harsons Laboratories 4th Nov. 2010

20938 H2010/20938/686 Suxamethonium

Chloride

Injection Suxamethonium Chloride Bp 50mg Harsons Laboratories 4th Nov. 2010

21908 H2010/21908/687 Amoxicap 500

Capsules Amoxicillin (As Trihydrate) 500mg Hovid Bhd 4th Nov. 2010

22024 H2010/22024/688 Zolevox-500

Tablets Levofloxacin Hemihydrates Equivalent To Levofloxacin 500mg

Innocia Lifesciences Pvt Ltd

4th Nov. 2010

22185 H2010/22185/689 Ramitash Ht-5

Tablets Ramipril 5mg; Hydrochlorothiazide 12.5mg

Intas Pharmaceuticals Ltd

4th Nov. 2010

21956 H2010/21956/690 Glycinorm-Mr 30 Tablets Gliclazide Bp 30mg Ipca Laboratories Ltd 4th Nov. 2010

19132 H2010/19132/691 Pan-Cetriaxone

1gm

Injection Ceftriaxone Sodium Equivalent To

Ceftriaxone 1gm

Laboratoires Pan-

Pharma 4th Nov. 2010

21144 H2010/21144/692 Malarate Tablets Lumefantrine 120mg; Artemether 20mg

Laboratory And Allied 4th Nov. 2010

22012 H2010/22012/693 Adiflam Gel Diclofenac 30g Leben Laboratories 4th Nov. 2010

22008 H2010/22008/694 Ibut-200 Tablets Brufen 200mg Leben Laboratories 4th Nov. 2010

22009 H2010/22009/695 Ibut-400 Tablets Brufen 400mg Leben Laboratories 4th Nov. 2010

21832 H2010/21832/696 Coveram 5mg/5mg Tablets 3.395mg Perindopril Coresponding To

5mg Perindopril Arginine; 6.935mg Amlodipine Besilate Equivalent To

5mg Amodipine

Les Laboratores

Servier 4th Nov. 2010

21830 H2010/21830/697 Coveram

10mg/5mg Tablets Perindopril Argeine 6.935mg;

Amlodipine 5mg

Les Laboratores

Servier 4th Nov. 2010

21829 H2010/21829/698 Coveram 10mg/10mg

Tablets 6.790mg Perindopril Corresponding To 10mg Perindopril Arginine; 13.870mg

Amlodipine Besilate Equivalent To 10mg Amlodipine

Les Laboratores Servier

4th Nov. 2010

21831 H2010/21831/699 Coveram 5mg/10mg

Tablets 3.395mg Perindopril Coresponding To 5mg Perindopril Arginine; 13.870mg

Amlodipine Besilate Equivalent To 10mg Amlodipine

Les Laboratores Servier

4th Nov. 2010

21718 H2010/21718/700 Nepin Sr-20 Tablets Nifedipine 20mg Lincoln 4th Nov. 2010

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Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

Pharmaceuticals

21591 H2010/21591/701 Flucomol Capsules Paracetamol Bp 500mg;

Dextromethorpham Hydrobromide Bp 15mg; Chlorpheniramine Maleate

Bp 2mg; Phenylepherine Hydrochloride Bp 10mg

Lincoln

Pharmaceuticals 4th Nov. 2010

16216 H2010/16216/702 Flucan 150mg Tablets Fluconazole 150mg Lincoln

Pharmaceuticals 4th Nov. 2010

21771 H2010/21771/703 Primacort-100 Injection Hydrocortisone Sodium Succinate

100mg

Macleods

Pharmaceuticals 4th Nov. 2010

21901 H2010/21901/704 Paracetamol 500mg

Tablets Paracetamol 500mg Macleods Pharmaceuticals

4th Nov. 2010

21809 H2010/21809/705 Atenolol Tablets Atenolol Bp 50mg Macleods

Pharmaceuticals 4th Nov. 2010

21811 H2010/21811/706 Accuzon 1g Injection Ceftriaxone Sodium Bp Equivalent To

Ceftriaxone Anhydrous 1g

Macleods

Pharmaceuticals 4th Nov. 2010

20848 H2010/20848/707 Furomark-500 Tablets Cefuroxime Axetil U.S.P (Amorphous)

Equivalent To Cefuroxime 500mg Marksans Pharma Ltd 4th Nov. 2010

20847 H2010/20847/708 Furomark-250 Tablets Cefuroxime Axetil U.S.P (Amorphous) Equivalent To Cefuroxime250mg

Marksans Pharma Ltd 4th Nov. 2010

22088 H2010/22088/709 Tenofovir

Disolproxil

Fumarate/Lamivudine/Efavirenz

Tablets Tenofovir Disolproxil Fumarate

300mg; Lamivudine Usp 300mg;

Efavirenz 600mg

Matrix Laboratories

Ltd 4th Nov. 2010

21584 H2010/21584/710 Carbamazepine Tablets Carbamazepine 200mg Medisel (K) Ltd 4th Nov. 2010

21583 H2010/21583/711 Prednisolone 5mg Tablets Pednisolone 5mg Medisel (K) Ltd 4th Nov. 2010

21758 H2010/21758/712 Arco Tablets Naphthoquine 100mg; Artemisinin 250mg

Medisel (K) Ltd 4th Nov. 2010

22079 H2010/22079/713 Emstat 20 Tablets Atorvastatin 20mg Medopharm Ltd 4th Nov. 2010

22078 H2010/22078/714 Metformin Tablets Metformin 500mg Medopharm Ltd 4th Nov. 2010

18705 H2010/18705/715 Medcefur 250mg Tablets Cefuroxime Axetil U.S.P Equivalent

To Cefuroxime 250mg Medopharm Ltd 4th Nov. 2010

19668 H2010/19668/716 Cledomox 625 Tablets Amoxicillin 500mg And Clavulanic Acid 125mg

Medopharm Ltd 4th Nov. 2010

19669 H2010/19669/717 Cledomox 375 Tablets Amoxicillin 250 And Clavulanic Acid

125mg Medopharm Ltd 4th Nov. 2010

21378 H2010/21378/718 Trimoprim-480 Ta Tablets Sulphamethoxazole B.P 400mg;

Trimethoprim B.P 80mg Medreich Plc 4th Nov. 2010

22046 H2010/22046/719 Maxlen-70 Tablets Alendronate Sodium Trihydrate

91.37mg Mega Life Sciences 4th Nov. 2010

21290 H2010/21290/720 Nestral Er-1000 Tablets Nicotinic Acid Bp 1000mg Mega Life Sciences 4th Nov. 2010

20120 H2010/20120/721 Nilgar M-30 Tablets Pioglitazone Hydrochloride

Equivalent To Pioglitazone 30mg; Metformin Hydrochloride 500mg

Mega Life Sciences 4th Nov. 2010

20121 H2010/20121/722 Nilgar M-15 Tablets Pioglitazone Hydrochloride

Equivalent To Pioglitazone 15mg; Metformin Hydrochloride 500mg

Mega Life Sciences 4th Nov. 2010

22044 H2010/22044/723 Incros Injection Elemental Iron As Fe+3 20mg Mega Life Sciences 4th Nov. 2010

19707 H2010/19707/724 Medicoff Clear Capsules Guaifenesin 200mg; Pseudo Ephedrine Hcl 30mg; Dextromethorphon

Hydrobromide 10mg

Mega Life Sciences 4th Nov. 2010

22049 H2010/22049/725 Flexsa 1500 Sachet Glucosamine Sulphate 1500mg Mega Life Sciences 4th Nov. 2010

21055 H2010/21055/726 Nasivion 0.01%

(Mini) Nasal Solution Oxymetazoline Hydrochloride Usp

0.1mg Merck South Africa 4th Nov. 2010

21660 H2010/21660/727 Becoactin Tablets Cyproptadine Hydrochloride Usp

4mg; Vitamin B1 2mg; Vitamin B2 0.5mg; Nicotinamide P 10mg; Vitamin

B12 1mcg; Glycine Bp 40mg; Elemental Iron 8mg; Elemental Zinc 6mg

Meyers Organics Pvt 4th Nov. 2010

22047 H2010/22047/7283

Kipel 4 Tablets Montelukast Sodium Equivalent To Montelukast 4mg

Msn Labs For Mega Life Sciences Pty Ltd

4th Nov. 2010

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No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

20943 H2010/20943/729 Naprocap-500mg Tablets Capecitabine 500mg Naprod Life Sciences 4th Nov. 2010

21247 H2010/21247/730 Abingem 200 Injection Gemcitabine 200mg Naprod Life Sciences 4th Nov. 2010

21248 H2010/21248/731 Abingem 1g Injection Gemcitabine 1g Naprod Life Sciences 4th Nov. 2010

21635 H2010/21635/732 Lox 2% Local Anaesthetic

Lidocaine Hydrochloride Bp 21.3mg Neon Laboratories Limited

4th Nov. 2010

21786 H2010/21786/733 Neomet 850mg Tablets Metformin Hydrochloride Bp 850mg Neopharma 4th Nov. 2010

21787 H2010/21787/734 Neomet 1000mg Tablets Metformin Hydrochloride Bp 1000mg Neopharma 4th Nov. 2010

21785 H2010/21785/735 Neomet 500mg Tablets Metformin Hydrochloride Bp 500mg Neopharma 4th Nov. 2010

21790 H2010/21790/736 Neoday Tablets Loratadine 10mg Neopharma 4th Nov. 2010

21075 H2010/21075/737 Xefo Rapid 8mg Injection Lornoxicam 8mg Nycomed Pty 4th Nov. 2010

21073 H2010/21073/738 Xefo Rapid 8 Tablets Lornoxicam 8mg Nycomed Pty 4th Nov. 2010

21076 H2010/21076/739 Pantoloc 40mg Tablets Pantoprazole 40mg Nycomed Pty 4th Nov. 2010

22148 H2010/22148/740 Bromodel 2.5mg Tablets Bromocriptine 2.5mg Opsonin Pharma 4th Nov. 2010

20703 H2010/20703/741 Zopercin 4.5mg Injection Piperacillin 4g; Tazobactam 0.5g Orchid Healthcare Ltd 4th Nov. 2010

18438 H2010/18438/742 Rogophen 0.5% W/V

Eye Drops Chloramphenicol Bp 0.5mg Pliva Pakistan For Royal Group

4th Nov. 2010

18439 H2010/18439/743 Rogogent Eye/Ear Drops Gentamicin Sulphate Bp Equivalent

To Gentamicin 0.3% W/V

Pliva Pakistan For

Royal Group 4th Nov. 2010

21240 H2010/21240/744 Pelastin Injection Imipenem 500mg; Cilastatin Sodium

Equivalent To Cilastatin 500mg Pt Sanbe Farma 4th Nov. 2010

19988 H2010/19988/745 Claneksi Forte Suspension Amoxicillin Trihydrate Usp

Equivalent To Amoxicillin 250mg; Clavulanate Potassium 62.5mg

Pt Sanbe Farma 4th Nov. 2010

21885 H2010/21885/746 Relipoietin

2,000iu Injection 2,000iu Of Erythropoietin

Concentrated Solution Ph. Eur

Reliance Life Sciences

Pvt Ltd 4th Nov. 2010

17209 H2010/17209/747 Roaccutane 10 Capsules Isotretinoin 10mg Hoffmann-La Roche

Ltd 4th Nov. 2010

17210 H2010/17210/748 Roaccutane 20 Capsules Isotretinoin 20mg Hoffmann-La Roche Ltd

4th Nov. 2010

21526 H2010/21526/749 Coflite Syrup Diphenhydramine Hcl 7.5mg; Sodium

Citrate 28.5mg Sky Light Chemicals 4th Nov. 2010

21529 H2010/21529/750 Sky-L Gripe Sodium Bicarbonate Sky Light Chemicals 4th Nov. 2010

21528 H2010/21528/751 Phenamine Syrup Chlorpheniramine Maleate 2mg Sky Light Chemicals 4th Nov. 2010

21527 H2010/21527/752 Flagilite Suspension Metronidazole Bp 200mg (As Benzoate)

Sky Light Chemicals 4th Nov. 2010

21525 H2010/21525/753 Sky-Mol Suspension Paracetamol Bp 120mg Sky Light Chemicals 4th Nov. 2010

22207 H2010/22207/754 Ibulite 60ml Suspension Ibuprofen Bp 100mg Sky Light Chemicals 4th Nov. 2010

22208 H2010/22208/755 Albalite Suspension Albendazole Usp 400mg Sky Light Chemicals 4th Nov. 2010

20595 H2010/20595/756 Diclofenac Sodium

75mg/3ml Injection Diclofenac Sodium 75mg Spi 4th Nov. 2010

17503 H2010/17503/757 Stacef 250mg Injection Ceftriaxone Sodium U.S.P Equivalent

To Ceftriaxone 250mg Stallion Laboratories 4th Nov. 2010

17505 H2010/17505/758 Cestazid 1000mg Injection Ceftazidine U.S.P 1000mg Stallion Laboratories 4th Nov. 2010

17504 H2010/17504/759 Stacef 1000mg For Injection Ceftriaxone Sodium U.S.P Equivalent

To Ceftriaxone 1000mg Stallion Laboratories 4th Nov. 2010

18662 H2010/18662/760 Efavirenz 200mg Tablets Efavirenz 200mg Strides Arcolab Ltd 4th Nov. 2010

20517 H2010/20517/761 Keta Injection Ketamine Hcl Usp Equivalent To

Ketamine 50mg Swiss Parenterals Ltd 4th Nov. 2010

18186 H2010/18186/762 Bactacef 1gm Injection Sulbactam Sodium Usp Equivalent To Sulbactam 0.5gm; Cefoperazone

Sodium Usp Equivalent To Cefoperazone 0.5gm

Swiss Parenterals Ltd 4th Nov. 2010

17675 H2010/17675/763 Calxy-625 Tablets Amoxicillin Trihydrate Bp Equivalent

Amoxicillin 500mg; Clavulanate

Potassium Usp Clavulanic Acid 125mg

Swiss Pharma Pvt Ltd 4th Nov. 2010

21455 H2010/21455/764 Antiplatt Plus 150 Tablets Clopidogrel 75mg; Aspirin Usp 150mg Troikaa Laboratories 4th Nov. 2010

20945 H2010/20945/765 Troypofol I.V 1%

W/V Injection Propofol Bp 10,G Troikaa Laboratories 4th Nov. 2010

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THE KENYA GAZETTE 3rd August, 2011

2964

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

21340 H2010/21340/766 Telsar 80 Tablets Telmisartan 80mg Unichem Laboratories

Ltd 4th Nov. 2010

20815 H2010/20815/767 Corbis-H5 Tablets Bisoprol Fumarate Usp 5mg; Hydrochlorothiazide Usp 6.25mg

Unichem Laboratories Ltd

4th Nov. 2010

21523 H2010/21523/768 Tizigesic 2mg Tablets Tizanidine Hcl 2mg Unichem Laboratories

Ltd 4th Nov. 2010

21789 H2010/21789/769 Neoxicam 15 Tablets Meloxicam 15mg Neopharm 4th Nov. 2010

21788 H2010/21788/770 Neoxicam 7.5 Tablets Meloxicam 7.5mg Neopharm 4th Nov. 2010

19688 H2010/19688/771 Calamine Lotion Calamine 15%; Zinc Oxide 5% Universal Corporation 4th Nov. 2010

20488 H2010/20488/772 Virom 20mg Capsules Omeprazole Bp 20mg Virchow Healthcare

Ltd 4th Nov. 2010

21864 H2010/21864/773 Carbagen Tablets Carbamazepine 200mg Yanzhou Xier Kangtai

Pharmaceuticals Co. Ltd For Shanghai

Agen Int. Trade Co. Ltd

4th Nov. 2010

21867 H2010/21867/774 Ceftriagen 1g B.-

Im/Iv Injection Ceftriaxone Sodium Bp Equivalent To

Ceftriaxone 1g

Yanzhou Xier

Kangtai

Pharmaceuticals Co. Ltd For Shanghai

Agen Int. Trade Co. Ltd

4th Nov. 2010

21938 H2010/21938/775 Gentagen Im/Iv Injection Gentamycin 80mg/2ml Yanzhou Xier

Kangtai Pharmaceuticals Co.

Ltd For Shanghai Agen Int. Trade Co.

Ltd

4th Nov. 2010

20728 H2010/20728/776 Zeecid Tablets Dried Aluminium Hydroxide Gel Bp

120mg; Magnessium Trisilicate Bp 250mg

Zest Pharma 4th Nov. 2010

21752 H2010/21752/777 Imich Cream Imiquimod 50mg Zhuhai Ltd 4th Nov. 2010

21727 H2010/21727/778 Loradine Tablets Loratadine 10mg Y.S.P Industries 4th Nov. 2010

22192 H2010/22192/779 Tasone 15g Cream Bentamethasone Diproprionate Cream Usp 0.065% W/W

Centaur Pharmaceuticals

4th Nov. 2010

21896 H2010/21896/780 Breathezy 10 Tablets Montelukast Sodium Equivalent To

Montelukas 10mg Msn Laboratories Ltd 4th Nov. 2010

22193 H2010/22193/781 Netasole Cream Betamethasone (As 17-Valerate) Bp

0.1g; Neomycin Sulphate Bp 0.5g

Centaur

Pharmaceuticals 4th Nov. 2010

21894 H2010/21894/782 Safetelmi 40 Tablets Telmisartan Ph. Eur. 40mg Msn Laboratories Ltd 4th Nov. 2010

21893 H2010/21893/783 Ldnil 10 Tablets Rosuvastatin 10mg Msn Laboratories Ltd 4th Nov. 2010

22226 H2010/22226/784 Aurosol Eye Drops Hypromellose 7.0% W/V Aurolab 4th Nov. 2010

21810 H2010/21810/785 Omepraz-20 Capsules Omeprazole Bp 20mg Macleods Pharmaceuticals

4th Nov. 2010

21297 H2010/21297/786 Panadol

240mg/5ml Elixir Syrup Paracetamol 120mg Glaxosmithkline 4th Nov. 2010

20441 H2010/20441/787 Finfive Tablets Finasteride Usp 5mg Unicure Remedies Ltd 4th Nov. 2010

21895 H2010/21895/788 Plasep Tablets Clopidogrel Bisulfate Usp 75mg Msn Laboratories Ltd 4th Nov. 2010

21944 H2010/21944/789 Indoplant Implant Levonogestrel 75mg Pt-Triyasa Nagamas 4th Nov. 2010

21976 H2010/21976/790 Tx-Eye Ointment Tetracycline 1% W/W Galentic Pharma

(India) Pvt Ltd 4th Nov. 2010

22195 H2010/22195/791 Entezma Ointment Betamethasone 0.5mg; Salicylic Acid Bp 30mg

Centaur Pharmaceuticals

4th Nov. 2010

21531 H2010/21531/792 Allerfast 180mg Tablets Fexofenadine Hcl 180mg Khandelwal

Laboratories Ltd 4th Nov. 2010

21742 H2010/21742/793 Carefenac 100mg Tablets Diclofenac Sodium 100mg Shanxi Guangsheng 4th Nov. 2010

18413 H2010/18413/794 Bonestat Capsules Calcium Carbonate Bp 500mg

Equivalent To Elemental Calcium 200mg, Zinc Sulphate H20 Usp 7.5, Calcitriol Bp 0.25mcg

Indichemie Health

Specialities Ltd 4th Nov. 2010

21154 H2010/21154/795 Telmimark 80 Tablets Telmisartan 80mg Marksans Pharma Ltd 4th Nov. 2010

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3rd August, 2011 THE KENYA GAZETTE 2965

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

21741 H2010/21741/796 Brufol-200mg Tablets Ibuprufen 200mg Shanxi Guangsheng 4th Nov. 2010

21155 H2010/21155/797 Telmimark 40 Tablets Telmisartan 40mg Marksans Pharma Ltd 4th Nov. 2010

21747 H2010/21747/798 Brufol-400mg Tablets Ibuprufen 400mg Shanxi Guangsheng 4th Nov. 2010

21156 H2010/21156/799 Acixx Suspension Magaldrate 480mg; Simethicone 25mg Marksans Pharma Ltd 4th Nov. 2010

18412 H2010/18412/800 Celfast Tablets Aceclofenac Bp 100mg; Paracetamol

Bp 500mg

Indichemie Health

Specialities Ltd 4th Nov. 2010

19969 H2010/19969/801 Fantem Suspension Artemether 0.180g; Lumefantrine 1.080g Per 60ml

Madras For Medinomics

Healthcare Pvt Ltd

4th Nov. 2010

20858 H2010/20858/802 Pozineg 2000 Injection Cefepime 2000mg Aurobindo Pharma

Limited 4th Nov. 2010

20778 H2010/20778/803 Meromark 1g Injection Meropenem Trihydrate U.S.P Equivalent To Anhydrous Meropenem

1g, Sodium Carbonate Equivalent To Sodium 90.2mg

Marksans Pharma Ltd 4th Nov. 2010

21462 H2010/21462/804 Ramicip-H Tablets Ramipril 2.5mg, Hydrochlorthiazide

12.5mg Cipla Ltd 2nd Dec 2010

21798 H2010/21798/805 Sterimax 2.5% V/V Chlorhexidine Gluconate

Solution Ip, 0.5% W/V Triclosan Usp, 50% V/V Isopropyl Alcohol (2-

Propanol) Bp, Skin Emollients, Perfume, Brilliant Blue Fcf As Colour

Coral Clinical Systems 2nd Dec 2010

21799 H2010/21799/806 Endomax Solution Glutaraldehyde 2.45% W/V Coral Clinical Systems 2nd Dec 2010

21800 H2010/21800/807 Endomax 2.0 Solution Glutaraldehyde 2% W/V Coral Clinical Systems 2nd Dec 2010

20605 H2010/20605/808 Fenplus Tablets Ibuprofen Bp 400mg, Paracetamol Bp

325mg Coral Laboratories 2nd Dec 2010

21732 H2010/21732/809 Clavodran 625mg Tablets Amoxicillin 500mg, Clavulanic Acid 125mg

Dar Al Dawa, Nau'r Jordan

2nd Dec 2010

21733 H2010/21733/810 Clavodran 1mg Tablets Amoxicillin 875mg, Clavulanic Acid

125mg

Dar Al Dawa, Nau'r

Jordan 2nd Dec 2010

18731 H2010/18731/811 Cetriz Syrup Cetrizine Hydrochloride Bp 5mg Dawa Limited 2nd Dec 2010

21691 H2010/21691/812 Zofra Odt 4 Tablets Ondansetron Usp 4mg Eskayef Bangladesh

Ltd 2nd Dec 2010

21692 H2010/21692/813 Carbazin Cr Tablets Carbamazepine 200mg Eskayef Bangladesh

Ltd 2nd Dec 2010

20622 H2010/20622/814 Vitalipid

Novumadult Injection Vitamin A 99µG, Vitamin D2 0.5µG,

Vitamin E 0.91mg, Vitamin K1 15µG Fresenius Kabi 2nd Dec 2010

19579b H2010/19579b/815

Co-Tasmi 80mg/12.5mg

Tablets Telmisartan 80mg, Hydrochlorthiazide 12.5mg

Getz Pharma 2nd Dec 2010

22249 H2010/22249/816 Fungiter Cream Terbinafine Hydrochloride Bp 1%

W/W

Global Pharma

Healthcare Pvt Ltd 2nd Dec 2010

22035 H2010/22035/817 Rostat-5 Tablets Rosuvastatin Calcium Equivalent To

Rosuvastatin 5mg

Innocia Lifesciences

Pvt Ltd 2nd Dec 2010

22028 H2010/22028/818 Cetlevo-5 Tablets Levocetirizine Dihydrochloride 5mg Innocia Lifesciences

Pvt Ltd 2nd Dec 2010

22022 H2010/22022/819 Rostat-10 Tablets Rosuvastatin 10mg Innocia Lifesciences Pvt Ltd

2nd Dec 2010

22021 H2010/22021/820 Rabosec -20 Tablets Rabeprazole Sodium 20mg Innocia Lifesciences

Pvt Ltd 2nd Dec 2010

20784 H2010/20784/821 Maclair-10 Tablets Montelukast Sodium Equivalent To

Montelukast 10mg

Mac Heal Laboratories

Ltd 2nd Dec 2010

22097 H2010/22097/822 Zinc Sulfate Tablets Elemental Zinc 20mg Macleods

Pharmaceuticals 2nd Dec 2010

16747 H2010/16747/823 Oflomac I.V Injection Oloxacin Usp 200mg Macleods Pharmaceuticals

2nd Dec 2010

20617 H2010/20617/824 Paracetamol

Infusion 10mg/Ml Injection Paracetamol Bp 10mg Marck Biosciences Ltd 2nd Dec 2010

21913 H2010/21913/825 Hipoflox Eye/Ear Drops

Drops Ofloxacin U.S.P 0.3% W/V, Benzalkonium Chloride N.F 0.01% W/V

Marck Biosciences Ltd 2nd Dec 2010

20639 H2010/20639/826 Bactrid Suspension 100mg Cefixime U.S. P Medicraft

Pharmaceuticals (Pvt) 2nd Dec 2010

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2966

Appl.

No.

Proposed Reg.

No. Trade Name Dosage Form Active Ingredients Market Authorisation

Holder Date Of Reg

Ltd

20640 H2010/20640/827 Bactrid 400mg Capsules 400mg Cefixime U.S. P Medicraft

Pharmaceuticals (Pvt) Ltd

2nd Dec 2010

21292 H2010/21292/828 Rocimus 0.03%

W/W Ointment Tacrolimus Ointment 0.03% Mega Products Ltd 2nd Dec 2010

21513 H2010/21513/829 Neocuron Injection Pancuronium 2m/Ml Neon Labs 2nd Dec 2010

21149 H2010/21149/830 Pirsek 20/1100mg Capsules Omeprazole 20mg, Sodium

Bicarbonate 1100mg

Norwich

Pharmaceuticals For Glaxosmithkline

2nd Dec 2010

21150 H2010/21150/831 Pirsec 40/1100mg Capsules Omeprazole 40mg, Sodium

Bicarbonate 1100mg

Norwich

Pharmaceuticals For

Glaxosmithkline

2nd Dec 2010

21074 H2010/21074/832 Pantoloc 40mg Injection Pantoprazole 40mg Nycomed 2nd Dec 2010

20108 H2010/20108/833 Benylin Wet

Cough Expectorant

Syrup Guaifenesin 100mg Johnson&Johnson For

Surgipharm Limited. 2nd Dec 2010

20109 H2010/20109/834 Benylin Wet

Cough Expectorant

Syrup Guaifenesin 200mg Johnson&Johnson For

Surgipharm Limited. 2nd Dec 2010

19254 H2010/19254/835 Benlin For Colds Tablets Pseudoephedrine Hcl 30mg, Ibuprofen

200mg Pfizer Healthcare Ltd 2nd Dec 2010

19224 H2010/19224/836 Unistem V-1

Vaginal Tablets And Unisten

Cream

Tablets/Cream Clotrimazole Bp 500mg, Clotrimazole

Bp 1%

Regal

Pharmaceuticals Ltd 2nd Dec 2010

21857 H2010/21857/837 E-Gel Ds Capsules Vitamin E Usp 400 I.U Renata Limited 2nd Dec 2010

21852 H2010/21852/838 Gaba 300mg Tablets Gabapentin 300mg Renata Limited 2nd Dec 2010

21859 H2010/21859/839 E-Gel Capsules Vitamin-E Usp 200 I.U Renata Limited 2nd Dec 2010

21419 H2010/21419/840 Clexane Mdv 300mg/3ml

Injection Enoxaparin Sodium 300mg Sanofi Aventis 2nd Dec 2010

21698 H2010/21698/841 Coaprovel

300/25mg Tablets Irbesartan 300mg,

Hydrochlorothiazide 25mg Sanofi Aventis 2nd Dec 2010

21697 H2010/21697/842 Amaryl M Sr Tablet Glimepiride, Metformin Hydrochloride Sanofi Aventis 2nd Dec 2010

21701 H2010/21701/843 Zobenol 400mg Tablets Albendazole 400mg Sanofi Aventis -

Withrop Pharm 2nd Dec 2010

16238 H2010/16238/844 Indomethacin Capsules Indomethacin Bp 25mg Sishui Xierkang For

Royal Group 2nd Dec 2010

21914 H2010/21914/845 Neodex Eye/Ear

Drops Drops Neomycin Sulphate, Dexamethasone

Sodium Phosphate Marck Biosciences Ltd 2nd Dec 2010

22132 H2010/22132/846 Memox Tablets Mebendazole U.S.P 100mg Universal Corporation 2nd Dec 2010

22128 H2010/22128/847 Memox Suspension Mebendazole U.S.P 100mg Universal Corporation 2nd Dec 2010

21212 H2010/21212/848 Clotrimazole

(20gm) Cream Clotrimazole 1% W/W Vital Healthcare Ltd 2nd Dec 2010

21226 H2010/21226/849 Adrivit Injection Adrenaline Bitartrate Bp Equivalent

To Adrenalline 1mg, Water For Injection Bp Q.S

Vital Healthcare Ltd 2nd Dec 2010

21215 H2010/21215/850 Metovit Injection Metochlorpramide 20mg Vital Healthcare Ltd 2nd Dec 2010

PRODUCTS REGISTERED IN JULY TO DECEMBER, 2010 VET

Appl. No.

Proposed Reg. No. Trade Name Dosage Form Active Ingredients Market Authorization

Holder

Date of Reg.

21941 V2010/21941/24 Ashtyl 20% Powder Tylosin 20% W/W Ashish Life

Sciences Pvt 25th Aug. 2010

21935 V2010/21935/25 Ashoxy 20% Powder Oxytetracycline Hcl Bp 200mg Ashish Life Sciences Pvt

25th Aug. 2010

21348 V2010/21348/26 Albendazole 10% Suspension Albendazole 100mg Assia Animal

Health 25th Aug. 2010

21349 V2010/21349/27 Albendazole 2.5% Suspension Albendazole 25mg Assia Animal

Health 25th Aug. 2010

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3rd August, 2011 THE KENYA GAZETTE 2967

Appl.

No. Proposed Reg. No. Trade Name Dosage Form Active Ingredients Market

Authorization Holder

Date of Reg.

13733 V2010/13733/28 Wormizan Plus Suspension Levamisole Hydrochloride Bp

Vet 1.5% W/V; Oxyclozanide Bp

Vet 3.0% W/V Vet

Biodeal

Laboratories

Limited

25th Aug. 2010

19617 V2010/19617/29 Butaline Injection Buparvaquone 50mg Ceva Sante Animale 25th Aug. 2010

21387 V2010/21387/30 Dawafer Injection Iron Dextran 10% W/V Chongqing

Fangtong For Dawa Limited

25th Aug. 2010

21627 V2010/21627/31 Damectin 1% Injection Ivermectin 100mg Dawa Ltd 25th Aug. 2010

21605 V2010/21605/32 Dabendazole 300mg Tablets Albendazole Usp 300mg Dawa Ltd 25th Aug. 2010

21725 V2010/21725/33 Dabendazole 2500mg Bolus Albendazole Usp 2500mg Dawa Ltd 25th Aug. 2010

21891 V2010/21891/34 Dawaboost Injection Vitamin A 15000iu; Vitamin E

20mg; Vitamin D3 1000iu; Vitamin B1 10mg; Vitamin B2

5mg; Vitamin B6 3mg; Vitamin B12 50mcg; Vitamin B3 35mg;

Vitamin B5 25mg

Chongqing

Fangtong For Dawa Ltd

25th Aug. 2010

19642 V2010/19642/35 Trisulmycine Forte Powder Trimethoprim 13.3gm; Sulphadiazine Sodium

Equivalent To Sulphadiazine 67.7gm

Laprovet Company 25th Aug. 2010

17908 V2010/17908/36 Canazol-2.5% Suspension Albendazole Usp 25mg Nerix Pharma For

Pamoja Vetagro

Services

25th Aug. 2010

21176 V2010/21176/37 Diadin Injectable Injection Sulphadimidine Sodium Bp 0.333gm

Renata Ltd 25th Aug. 2010

21983 V2010/21983/38 Wofur Injection Ceftiofur 50mg/Ml Wockhardt Limited 25th Aug. 2010

21201 V2010/221201/39 Iron D Injection Iron Dextran 100mg Eagle Vet Tech. Co. Ltd

4th Nov. 2010

20430 V2010/20430/40 Tylo Pc Injection Tylosin Tartarate 57.5mg;

Thiamphenicol 200mg;

Prednisolone 5.0mg

Eagle Vet Tech. Co.

Ltd 4th Nov. 2010

20684 V2010/20684/41 Clopidol 25 Veterinary

Powder Clopicol 250gm Koffolk (1949) Ltd For Abic

4th Nov. 2010

21171 V2010/21171/42 Helmex Tablets Albendazole Usp 600mg Renata 4th Nov. 2010

21068 V2010/21068/43 Cevac Ibd L Injection Infectious Bursal Disease Vaccine

Ceva Sante Animale 4th Nov. 2010

22201 V2010/22201/44 Avi Pro Nd-Ibd Lasota Injection 108 Nd Virus, Strain La Sota 10

3

Eid50 Ib Virus

Lohman Animal

Health 4th Nov. 2010

20993 V2010/20993/45 Norodine Tablets Sulphadiazine Usp 1g;

Trimethoprim Usp 200mg Norbrook Labs 4th Nov. 2010

21611a V2010/21611a/46 Altramycin La Injection Oxytetracycline Dehydrate B.P

Equivalent To Oxytetracycline (On Anhydrous Basis) 200mg; 2-

Pyrroliodone Q.S

Vetnex Animal

Health Limited 4th Nov. 2010

22263 V2010/22263/047 Levanide Injection Levamisole Hcl Bp 15mg, Rafoxanide Bp 30mg

Nerix Pharma Ltd For Megascope

2nd Dec 2010

20840 V2010/20840/048 Levazole Drench Levamizole Hcl 1.5% W/V Medina Chemicals 2nddec 2010

18311 V2010/18311/049 Bomatak Pour On Liquid Oxfendazole 75gm Bomac Laboratories 2nd Dec 2010

F. M. SIYOI,

Deputy Registrar.

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