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© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
9 June 2017 EMA/381816/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance(s): ambroxol
Procedure No.: PSUSA/00000130/201609
EMA/381816/2017 Page 2/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
AMBROXOL TEVA CONSEIL 30 mg, comprimé
not available NL19993 TEVA SANTÉ FR
AMBROXOL TEVA CONSEIL 0,3 %, solution buvable
not available NL19994 TEVA SANTÉ FR
Mucosolvan® Brausetabletten 60 mg not available 12801.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Ambroxol WICK Schleimlöser für Kinder 3 mg/ml Lösung zum Einnehmen
not available 38566.00.00 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
DE
Ambrosan 15 mg/5 ml sirup not available 52/703/99-C PRO.MED.CS PRAHA A.S. CZ
Ambrosan 15 mg tablety not available 52/094/13-C PRO.MED.CS PRAHA A.S. CZ
Mucosolvan® Lutschpastillen 15 mg not available 17548.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Ambroxolhydrochlorid "Unither Pharmaceuticals"
DE/H/5058/001 54317 UNITHER PHARMACEUTICALS DK
Ambroxol Hydrochloride Unither Pharmaceuticals 30 mg solution buvable en sachet
DE/H/5058/001 BE485937 UNITHER PHARMACEUTICALS BE
Ambroxolhydrochlorid Unither Pharmaceuticals 30 mg Lösung zum Einnehmen im Beutel
DE/H/5058/001 92428.00.00 UNITHER PHARMACEUTICALS DE
EMA/381816/2017 Page 3/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Ambroxol Hydrochloride Unither Pharmaceuticals 30 mg solution buvable en sachet
DE/H/5058/001 2016110269 UNITHER PHARMACEUTICALS LU
Mucosolvan® Injektionslösung 15 mg/2 ml
not available 89.01.01 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Mucibrón 3 mg/ ml solución oral not available 56538 LABORATORIOS NORMON, S.A. ES
AMBROSAN 15 mg/5 ml sirup not available 52/0100/00-S PRO.MED.CS PRAHA A.S. SK
CORYFIN ESPETTORANTE 3mg/ml sciroppo
not available 025311022 LABORATORIO FARMACEUTICO S.I.T. S.R.L.
IT
AMBROXOLO ABC 30 mg granulato per sospensione orale
not available 025105089 ABC FARMACEUTICI S.P.A. IT
AMBROXOLO ABC 15 mg granulato per sospensione orale
not available 025105077 ABC FARMACEUTICI S.P.A. IT
AMBROXOLO ABC 30 mg compresse not available 025105014 ABC FARMACEUTICI S.P.A. IT
AMBROXOLO ABC 30 mg supposte not available 025105065 ABC FARMACEUTICI S.P.A. IT
AMBROXOLO ABC 15 mg/2 ml soluzione da nebulizzare
not available 025105038 ABC FARMACEUTICI S.P.A. IT
VISCOMUCIL 3 mg/ml sciroppo not available 039872015 ABC FARMACEUTICI S.P.A. IT
Broncoliber not available 9545517 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
EMA/381816/2017 Page 4/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Mucosolvan® Tropfen 30 mg/2 ml Tropfen zum Einnehmen, Lösung
not available 14144.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Mucosolvan® Tropfen 30 mg/2 ml Tropfen zum Einnehmen, Lösung
not available 25685.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Mucosolvan® Kindersaft 15 mg/5 ml Lösung zum Einnehmen
not available 89.00.04 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Bromax 6 mg/ml xarope not available 9632711 FARMA 1000 - PRODUTOS FARMACÊUTICOS, LDA.
PT
Ambroxol 1A Pharma 7,5 mg/ml - Lösung
945.885 1-24729 1A PHARMA GMBH AT
FLUIBRON Bambini 15 mg granulato per sospensione orale
not available 024596114 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON Bambini 15 mg granulato per sospensione orale
not available 024596126 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON 15 mg/2 ml soluzione da nebulizzare
not available 024596052 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON 15 mg/5 ml sciroppo not available 024596037 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON 30 mg compresse not available 024596013 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON 30 mg compresse not available 024596025 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON Adulti 30 mg granulato per not available 024596090 CHIESI FARMACEUTICI S.P.A. IT
EMA/381816/2017 Page 5/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
sospensione orale
FLUIBRON Adulti 30 mg granulato per sospensione orale
not available 024596102 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON 15 mg/2 ml Soluzione da nebulizzare
not available 024596138 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON 15 mg/2 ml Soluzione da nebulizzare
not available 024596140 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON 15 mg/2 ml Soluzione da nebulizzare
not available 024596153 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON 7,5 mg/ml soluzione orale o da nebulizzare
not available 024596049 CHIESI FARMACEUTICI S.P.A. IT
FLUIBRON 15 mg/5 ml syrup (0.3% w/v)
not available 12668 VARNAVAS HADJIPANAYIS LTD. (LATSIA)
CY
FLUIBRON Adulti 30 mg compresse effervescenti
not available 024596189 CHIESI FARMACEUTICI S.P.A. IT
Ambroxolhydrochlorid Cyathus 10 mg/Sprühstoß Lösung zum Einnehmen
DE/H/2227/001 76711.00.00 CYATHUS EXQUIRERE PHARMAFORSCHUNGSGMBH
DE
Gogolox 10 mg/erogazione Soluzione orale
DE/H/2227/001 040831012 CYATHUS EXQUIRERE PHARMAFORSCHUNGSGMBH
IT
Gogolox 10 mg/erogazione Soluzione orale
DE/H/2227/001 040831024 CYATHUS EXQUIRERE PHARMAFORSCHUNGSGMBH
IT
EMA/381816/2017 Page 6/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Mucosolvan® Kindersaft 30 mg/5 ml not available 25684.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Bromax 120 mg cápsulas de libertação prolongada
not available 9755611 FARMA 1000 - PRODUTOS FARMACÊUTICOS, LDA.
PT
Clarvivo 20 mg sugetabletter med mintsmak
not available 14-10289 WEIFA AS NO
Clarvivo 20 mg sugetabletter med lakrissmak
not available 14-10290 WEIFA AS NO
Clarvivo mint 20 mg sugtablett not available 51720 WEIFA AS SE
Clarvivo lakrits 20 mg sugtablett not available 51721 WEIFA AS SE
Ambroxol WICK Schleimlöser für Kinder 3 mg/ml Lösung zum Einnehmen
not available 38566.00.00 WICK PHARMA ZWEIGNIEDERLASSUNG DER PROCTER & GAMBLE GMBH
DE
MUCOARICODIL 30 mg/10 ml sciroppo not available 033561034 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
MUCOARICODIL 30 mg/10 ml sciroppo not available 033561046 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
MUCOARICODIL 30 mg compresse not available 033561022 A. MENARINI - INDUSTRIE FARMACEUTICHE RIUNITE - S.R.L.
IT
Broncoliber 30 mg comprimidos not available 9545418 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
EMA/381816/2017 Page 7/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Mucosolvan® Retardkapseln 75 mg not available 89.00.06 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Ambrosan 15 mg tablety not available 52/094/13-C PRO.MED.CS PRAHA A.S. CZ
Mucosolvan® Infusionslösungskonzentrat 1000 mg/50 ml, Konzentrat zur Herstellung einer Infusionslösung
not available 89.00.05 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
MUCICLAR 15mg/2ml soluzione da nebulizzare
not available 025009097 PIAM FARMACEUTICI S.P.A. IT
MUCICLAR 15mg/5ml sciroppo not available 025009022 PIAM FARMACEUTICI S.P.A. IT
MUCICLAR 75mg capsule a rilascio prolungato
not available 025009059 PIAM FARMACEUTICI S.P.A. IT
MUCICLAR 30mg granulato per soluzione orale
not available 025009085 PIAM FARMACEUTICI S.P.A. IT
MUCICLAR Ambroxol
not available 037/00302 PIAM FARMACEUTICI S.P.A. MT
MUCICLAR Ambroxol
not available 037/00301 PIAM FARMACEUTICI S.P.A. MT
Mucosolvan® Tabletten 30 mg not available 89.01.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Ambrosan 15 mg tablety not available 52/094/13-C PRO.MED.CS PRAHA A.S. CZ
EMA/381816/2017 Page 8/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Ambroxol AbZ Hustensaft 15 mg/5 ml Lösung zum Einnehmen
not available 38565.00.00 ABZ-PHARMA GMBH DE
AMBROSAN 15 mg/5 ml sirup not available 52/0100/00-S PRO.MED.CS PRAHA A.S. SK
Mucoangin 2,5 mg/ pulvérisation, Solution pour pulvérisation buccale
BE/H/0181/003 BE449217 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucoangin 2,5 mg/verstuiving, spray voor oromucosaal gebruik, oplossing
BE/H/0181/003 BE449217 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucosolvan Perlonguets 75 mg cápsulas de libertação prolongada
not available 5490248 UNILFARMA LDA. PT
MUCOSOLVAN® not available 21127 BOEHRINGER INGELHEIM ELLAS AE CY
Lysopadol 20 mg Tροχίσκοι BE/H/0181/001 21500 BOEHRINGER INGELHEIM ELLAS AE CY
Mucoangin 20 mg szopogató tabletta not available OGYI-T-9384/05 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
HU
SURBRONC EXPECTORANT AMBROXOL SANS SUCRE, solution buvable édulcorée à l’acésulfame potassique et au sorbitol
not available 34009 327 409 2 5 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CITRON 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
BE/H/0181/001 34009 222 861 2 9 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
EMA/381816/2017 Page 9/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Mucoangin Munt 20 mg zuigtabletten BE/H/0104/001 BE426404 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucoangin Menthe 20 mg pastilles BE/H/0104/001 BE426404 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucoangin Minze 20 mg Lutschtabletten BE/H/0104/001 BE219177 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucoangin Minze 20 mg Lutschtabletten BE/H/0104/001 BE426404 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Zerinol Gola 20 mg pastiglie BE/H/0181/001 041239272 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola 20 mg pastiglie BE/H/0181/001 041239260 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola 20 mg pastiglie BE/H/0181/001 041239245 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola 20 mg pastiglie BE/H/0181/001 041239221 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola 20 mg pastiglie BE/H/0181/001 041239219 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola 20 mg pastiglie BE/H/0181/001 041239195 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola 20 mg pastiglie BE/H/0181/001 041239171 BOEHRINGER INGELHEIM ITALIA IT
EMA/381816/2017 Page 10/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
S.P.A.
Mucoangin Cassis 20 mg Lutschtabletten BE/H/0103/001 BE219064 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Surbronc 60 mg Filmtabletten not available BE141312 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Surbronc 30 mg/5 ml Sirup not available BE141136 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Surbronc 60 mg/3 g Pulver zur Herstellung einer Lösung zum Einnehmen
not available BE151015 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Surbronc 60 mg Filmtabletten not available 0632/02/09/6835 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Mucoangin Zitrone 20 mg Lutschtabletten
BE/H/0181/001 2012120181 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Surbronc 30 mg/5 ml Sirup not available 0632/02/09/6837 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Surbronc 60 mg/3 g Pulver zur Herstellung einer Lösung zum Einnehmen
not available 0632/02/09/6836 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Mucosolvan 30 mg tablete not available HR-H-896955635-01 BOEHRINGER INGELHEIM ZAGREB D.O.O.
HR
EMA/381816/2017 Page 11/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Mucosolvan 75 mg kapsule s produljenim oslobađanjem
not available HR-H-472120462-01 BOEHRINGER INGELHEIM ZAGREB D.O.O.
HR
Lizipadol 17,86 mg/ml solución para pulverización bucal
BE/H/0181/003 78669 BOEHRINGER INGELHEIM ESPANA S.A. ES
Mucosolvan 30mg/ 5 ml sirup not available 52/0108/02-S BOEHRINGER INGELHEIM INTERNATIONAL GMBH
SK
Lysopadol 17.86 mg/ml Oromucosal Spray, Solution
BE/H/0182/003 PA 7/63/2 BOEHRINGER INGELHEIM LTD. IE
Mucoangin Zitrone 20 mg Lutschtabletten
BE/H/0181/001 BE423263 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Rexambro 20 mg Lutschtabletten BE/H/0183/001 BE423297 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Bisolangin 20 mg Lutschtabletten BE/H/107/001 BE250171 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Bisolangin 20 mg pastilles BE/H/107/001 BE250171 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Bisolangin 20 mg zuigtabletten BE/H/107/001 BE250171 SCS BOEHRINGER INGELHEIM COMM.V.
BE
SURBRONC EXPECTORANT AMBROXOL 30 mg, comprimé sécable
not available 34009 327 405 7 4 BOEHRINGER INGELHEIM FRANCE FR
Mucoangin 2,5 mg/Sprühstoß, Spray zur Anwendung in der Mundhöhle,
BE/H/0181/003 BE449217 SCS BOEHRINGER INGELHEIM BE
EMA/381816/2017 Page 12/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lösung COMM.V.
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 17,86 mg/ml SANS SUCRE, solution pour pulvérisation buccale édulcorée au sucralose
BE/H/0181/003 34009 278 529 3 0 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique
BE/H/0181/001 34009 498 936 7 6 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique
BE/H/0181/001 34009 498 940 4 8 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique
BE/H/0104/001 34009 498 939 6 6 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique
BE/H/0181/001 34009 498 937 3 7 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au
BE/H/0181/001 34009 499 839 5 7 BOEHRINGER INGELHEIM FRANCE FR
EMA/381816/2017 Page 13/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
sorbitol et à la saccharine sodique
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique
BE/H/0181/001 34009 499 838 9 6 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique
BE/H/0181/001 34009 499 837 2 8 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique
BE/H/0181/001 34009 499 836 6 7 BOEHRINGER INGELHEIM FRANCE FR
Mucoangin Svartvinbär 20 mg sugtablett BE/H/0183/001 46188 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
SE
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
BG
Mucosolvan Max 75 mg capsule cu eliberare prelungită
not available 7323/2015/04 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosolvan Max 75 mg capsule cu eliberare prelungită
not available 7323/2015/03 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosolvan Max 75 mg capsule cu not available 7323/2015/02 BOEHRINGER INGELHEIM RO
EMA/381816/2017 Page 14/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
eliberare prelungită INTERNATIONAL GMBH
Mucosolvan Max 75 mg capsule cu eliberare prelungită
not available 7323/2015/01 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucoangin 2,5 mg/Sprühstoß, Spray zur Anwendung in der Mundhöhle, Lösung
BE/H/0181/003 2014060155 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Mucoangin 2,5 mg/ pulvérisation, Solution pour pulvérisation buccale
BE/H/0181/003 2014060155 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Lysopadol 2,5 mg/ψεκασμό στοματικό εκνέφωμα, διάλυμα
BE/H/0181/003 70850 BOEHRINGER INGELHEIM ELLAS AE GR
Lysopadol 2,5 mg/ψεκασμό στοματικό εκνέφωμα, διάλυμα
BE/H/0181/003 022023 BOEHRINGER INGELHEIM ELLAS AE CY
MUCOSOLVAN® not available 40921/11 BOEHRINGER INGELHEIM ELLAS AE GR
MUCOSOLVAN 30 mg/5 ml sciroppo in bustine monodose
not available 024428284 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN 30 mg/5 ml sciroppo in bustine monodose
not available 024428296 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN, 30 mg, comprimate not available 7694/2015/01 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
MUCOSOLVAN® not available 40920/11 BOEHRINGER INGELHEIM ELLAS AE GR
EMA/381816/2017 Page 15/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Zerinol Gola 2,5 mg/erogazione spray per mucosa orale, soluzione
BE/H/0181/003 041239296 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola 2,5 mg/erogazione spray per mucosa orale, soluzione
BE/H/0181/003 041239308 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Mucoangin Mint 20 mg, zuigtabletten BE/H/0107/001 RVG 30047 BOEHRINGER INGELHEIM B.V. NL
Mucoangin Mint, sugetabletter BE/H/0107/001 35595 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
DK
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 7/63/1 BOEHRINGER INGELHEIM LTD. IE
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
BE/H/0103/001 34009 392 589 1 1 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
BE/H/0103/001 34009 392 591 6 1 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
BE/H/0103/001 34009 392 592 2 2 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au
BE/H/0103/001 34009 392 594 5 1 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
EMA/381816/2017 Page 16/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
sorbitol et au sucralose
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
BE/H/0103/001 34009 392 588 5 0 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
BE/H/0103/001 34009 392 593 9 0 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
BE/H/0103/001 34009 392 595 1 2 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
BE/H/0103/001 34009 392 596 8 0 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
BISOLANGIN 20 MG ZUIGTABLETTEN BE/H/107/01 BE 250 171 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Bisolangin 20 mg pastilles BE/H/0107/001 BE 250 171 SCS BOEHRINGER INGELHEIM COMM.V.
BE
BISOLANGIN 20 MG LUTSCHTABLETTEN BE/H/0107/001 BE 250 171 SCS BOEHRINGER INGELHEIM COMM.V.
BE
EMA/381816/2017 Page 17/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
BISOLANGIN 20 MG PASTILLES BE/H/0107/001 BE 250171 SCS BOEHRINGER INGELHEIM COMM.V.
BE
BISOLANGIN 20 MG ZUIGTABLETTEN BE/H/0107/001 BE 250171 SCS BOEHRINGER INGELHEIM COMM.V.
BE
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
BE/H/0104/001 34009 362 059 4 6 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
BE/H/0104/001 34009 362 062 5 0 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
BE/H/0104/001 34009 362 057 1 0 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
BE/H/0104/001 34009 362 058 8 8 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au
BE/H/0104/001 34009 362 060 2 1 BOEHRINGER INGELHEIM FRANCE FR
EMA/381816/2017 Page 18/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
sorbitol et à la saccharine sodique.
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
BE/H/0104/001 34009 362 061 9 9 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
BE/H/0104/001 34009 362 064 8 9 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
BE/H/0104/001 34009 362 063 1 1 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
BE/H/0104/001 34009 362 416 1 9 BOEHRINGER INGELHEIM FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
BE/H/0104/001 34009 362 065 4 0 BOEHRINGER INGELHEIM FRANCE FR
Surbronc 30 mg/5 ml sirop not available 0632/02/09/6837 SCS BOEHRINGER INGELHEIM COMM.V.
LU
EMA/381816/2017 Page 19/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088019 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088021 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088033 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088058 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088108 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088045 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088060 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088072 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088084 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088096 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088110 BOEHRINGER INGELHEIM ITALIA IT
EMA/381816/2017 Page 20/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
S.P.A.
Surbronc 30 mg/5 ml sirop not available BE141136 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Surbronc 30 mg/5 ml siroop not available BE141136 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Surbronc 60 mg comprimés pelliculés not available 0632/02/09/6835 SCS BOEHRINGER INGELHEIM COMM.V.
LU
SURBRONC EXPECTORANT AMBROXOL 30 mg, comprimé sécable
not available 34009 327 403 4 5 BOEHRINGER INGELHEIM FRANCE FR
SURBRONC EXPECTORANT AMBROXOL 30 mg, comprimé sécable
not available 34009 559 554 12 BOEHRINGER INGELHEIM FRANCE FR
SURFACTAL 1g/50 ml soluzione per infusione
not available 026751026 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Lasolvan, 15 mg/5ml siirup not available 091594 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
EE
Mucoangin, 20 mg, tabletki do ssania not available 9766 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
PL
MUCOSOLVAN® not available 11681 BOEHRINGER INGELHEIM ELLAS AE CY
Mucoangin 20 mg szopogató tabletta not available OGYI-T-9384/01 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
HU
EMA/381816/2017 Page 21/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Mucoangin 20 mg szopogató tabletta not available OGYI-T-9384/04 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
HU
Mucosolvan Tablety 30 mg not available 52/0243/02-S BOEHRINGER INGELHEIM INTERNATIONAL GMBH
SK
Mucosan® 15 mg - Ampullen not available 1-17345 BOEHRINGER INGELHEIM RCV GMBH & CO KG
AT
Mucosolvan® not available 8501 BOEHRINGER INGELHEIM ELLAS AE GR
Mucosolvan 30 mg comprimidos not available 9574715 UNILFARMA LDA. PT
Mucosolvan 6 mg/ml xarope not available 3245586 UNILFARMA LDA. PT
Mucosolvan, 30 mg, tabletki not available R/1021 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
PL
Mucosan pediátrico 3mg/ml jarabe not available 56.156 BOEHRINGER INGELHEIM ESPANA S.A. ES
Mucosan 30 mg comprimidos not available 56.154 BOEHRINGER INGELHEIM ESPANA S.A. ES
Mucosolvan, 30 mg/5 ml, syrop not available R/1022 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
PL
Mucosan 6 mg/ml jarabe not available 68.110 BOEHRINGER INGELHEIM ESPANA S.A. ES
Mucosan 60 mg polvo para solución oral not available 59.170 BOEHRINGER INGELHEIM ESPANA S.A. ES
Mucosolvan 6 mg/ml xarope not available 3245685 UNILFARMA LDA. PT
SURBRONC EXPECTORANT AMBROXOL not available 34009 327 404 06 BOEHRINGER INGELHEIM FRANCE FR
EMA/381816/2017 Page 22/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
30 mg, comprimé sécable
Mucosolvan 6 mg/ml xarope not available 8574913 UNILFARMA LDA. PT
Motosol 7,5 mg/ml solución inyectable not available 56.155 BOEHRINGER INGELHEIM ESPANA S.A. ES
Mucosolvan Perlonguets 75 mg cápsulas de libertação prolongada
not available 8631119 UNILFARMA LDA. PT
Mucosolvan Max 75 mg capsule cu eliberare prelungită
not available 5836/2005/01 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosolvan Max 75 mg capsule cu eliberare prelungită
not available 5836/2005/02 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosan Retard 75 mg cápsulas de liberación prolongada
not available 60.102 BOEHRINGER INGELHEIM ESPANA S.A. ES
Mucosolvan Roztok k perorálnímu podání a k inhalaci
not available 52/121/81-C BOEHRINGER INGELHEIM INTERNATIONAL GMBH
CZ
Mucoangin, mundhulespray, opløsning BE/H/0181/003 51095 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
DK
Mucosolvan Max 75 mg capsule cu eliberare prelungită
not available 5836/2005/03 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosolvan Max 75 mg capsule cu eliberare prelungită
not available 5836/2005/04 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosolvan inhalacje 15 mg/2 ml płyn not available R/1025 BOEHRINGER INGELHEIM PL
EMA/381816/2017 Page 23/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
do inhalacji z nebulizatora INTERNATIONAL GMBH
Mucosolvan junior Sirup not available 52/123/81-C BOEHRINGER INGELHEIM INTERNATIONAL GMBH
CZ
Mucosolvan Junior 15 mg/5 ml, sirop not available 870/2008/01 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosolvan® not available 8501 BOEHRINGER INGELHEIM ELLAS AE GR
MUCOSOLVAN MINI, 15 mg/5 ml, syrop not available 18296 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
PL
Mucosolvan 15 mg/2 ml solução injectável
not available 8574608 UNILFARMA LDA. PT
MUCOSOLVAN® not available 11682 BOEHRINGER INGELHEIM ELLAS AE CY
Mucosolvan Tablety not available 52/122/81-C BOEHRINGER INGELHEIM INTERNATIONAL GMBH
CZ
МУКОСОЛВАН 30 mg таблетки not available 9600149 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
BG
МУКОСОЛВАН 30 mg/5ml сироп not available 9600148 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
BG
Mucosolvan® not available 8501 BOEHRINGER INGELHEIM ELLAS AE GR
MUCOSOLVAN® not available 19781 BOEHRINGER INGELHEIM ELLAS AE CY
Mucosolvan® 15 mg / 5 ml - Saft für not available 1-17347 BOEHRINGER INGELHEIM RCV GMBH & AT
EMA/381816/2017 Page 24/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Kinder CO KG
MUCOSOLVAN 15 mg/5 ml sciroppo– gusto lampone
not available 024428132 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN 15 mg/5 ml sciroppo - gusto frutti di bosco
not available 024428272 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
МУКОСОЛВАН МАКС 75 mg капсули с удължено освобождаване, твърди
not available 20060844 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
BG
МУКОСОЛВАН 15 mg/5 ml сироп not available 20060026 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
BG
Mucosolvan® 30 mg / 5 ml - Saft not available 1-19598 BOEHRINGER INGELHEIM RCV GMBH & CO KG
AT
MUCOSOLVAN 30 mg compresse not available 024428017 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN 30 mg/5 ml sciroppo not available 024428233 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN 30 mg/5 ml sciroppo not available 024428245 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN 30 mg/5 ml sciroppo not available 024428258 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN 60 mg granulato per soluzione orale
not available 024428169 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
EMA/381816/2017 Page 25/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Mucosolvan® 7,5 mg / 1 ml - Lösung not available 1-17346 BOEHRINGER INGELHEIM RCV GMBH & CO KG
AT
MUCOSOLVAN 7,5 mg/ml soluzione da nebulizzare
not available 024428144 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN bambini 30 mg supposte not available 024428082 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN long effect Tvrdé tobolky s prodlouženým uvolňováním
not available 52/141/91-C BOEHRINGER INGELHEIM INTERNATIONAL GMBH
CZ
Mucosolvan pro dospělé 30 mg/5 ml sirup
not available 52/231/05-C BOEHRINGER INGELHEIM INTERNATIONAL GMBH
CZ
Mucosolvan Retard 75 mg kapsuly s predĺženým uvoľňovaním
not available 52/0256/07-S BOEHRINGER INGELHEIM INTERNATIONAL GMBH
SK
Mucosolvan® retard 75 mg - Kapseln not available 1-18234 BOEHRINGER INGELHEIM RCV GMBH & CO KG
AT
LASOLVAN 15 mg/5 ml sīrups not available 95-0334 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
LV
Mucoangin Cassis 20 mg pastilles BE/H/0103/001 0632/06/08/8966 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Mucoangin Cassis 20 mg Lutschtabletten BE/H/0103/001 0632/06/08/8966 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Mucoangin Minze 20 mg Lutschtabletten BE/H/0104/001 0632/06/08/8967 SCS BOEHRINGER INGELHEIM LU
EMA/381816/2017 Page 26/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
COMM.V.
Mucoangin Menthe 20 mg pastilles BE/H/0104/001 0632/06/08/8967 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Motosol 3mg/ml jarabe not available 56.357 BOEHRINGER INGELHEIM ESPANA S.A. ES
Motosol Retard 75 mg cápsulas de liberación prolongada
not available 60.103 BOEHRINGER INGELHEIM ESPANA S.A. ES
MUCOSOLVAN 30 mg/5 ml sciroppo in bustine monodose
not available 024428284 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN 30 mg/5 ml sciroppo in bustine monodose
not available 024428296 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOANGIN BE/H/107/01 19952 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
DK
Mucoangin Munt 20 mg zuigtabletten BE/H/0104/001 BE219177 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucoangin Menthe 20 mg pastilles BE/H/0104/001 BE219177 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucosolvan® 15 mg - Lutschpastillen not available 1-29408 BOEHRINGER INGELHEIM RCV GMBH & CO KG
AT
Surbronc 60 mg comprimés pelliculés not available BE141312 SCS BOEHRINGER INGELHEIM COMM.V.
BE
EMA/381816/2017 Page 27/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Surbronc 60 mg filmomhulde tabletten not available BE141312 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Surbronc 60 mg/3 g poudre pour solution buvable
not available BE151015 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Surbronc 60 mg/3 g poeder voor drank not available BE151015 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucoangin Cassis 20 mg pastilles BE/H/0103/001 BE219064 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucoangin Cassis 20 mg zuigtabletten BE/H/0103/001 BE219064 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucoangin® Johannisbeere 20 mg - Lutschtabletten
BE/H/0103/001 1-24422 BOEHRINGER INGELHEIM RCV GMBH & CO KG
AT
Mucoangin® Mint 20 mg - Lutschtabletten
BE/H/0104/001 1-24423 BOEHRINGER INGELHEIM RCV GMBH & CO KG
AT
Lasolvan 15 mg/5 ml sirupas not available LT/1/95/0777/003 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
LT
Mucosolvan mäkké pastilky not available 52/0559/08-S BOEHRINGER INGELHEIM INTERNATIONAL GMBH
SK
МУКОСОЛВАН 15 mg пастили not available 20060843 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
BG
MUCOSOLVAN® not available 20696 BOEHRINGER INGELHEIM ELLAS AE CY
EMA/381816/2017 Page 28/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Mucosolvan 15 mg Měkké pastilky not available 52/635/09-C BOEHRINGER INGELHEIM INTERNATIONAL GMBH
CZ
Mucosolvan 15 mg pastiglie gommose not available 024428195 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Mucosolvan 15 mg pastiglie gommose not available 024428207 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Mucosolvan 15 mg pastiglie gommose not available 024428219 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
MUCOSOLVAN® not available 8501 BOEHRINGER INGELHEIM ELLAS AE GR
Mucoangin Spray 2,5mg, spray voor oromucosaal gebruik
BE/H/0181/003 RVG 112356 BOEHRINGER INGELHEIM B.V. NL
Mucoangin Mint 20 mg sugtablett BE/H/0107/001 19952 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
SE
MUCOSOLVAN 15 mg/2 ml soluzione da nebulizzare
not available 024428043 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
SURBRONC 60 mg, comprimé enrobé sécable
not available 34009 332 773 0 7 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
MUCOSOLVAN MAX, 75 mg, kapsułki o przedłużonym uwalnianiu, twarde
not available 23053 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
PL
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 17,86 mg/ml SANS SUCRE, solution pour pulvérisation
BE/H/0181/003 34009 300 110 8 9 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
EMA/381816/2017 Page 29/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
buccale édulcorée au sucralose
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088122 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088134 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088146 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088159 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088161 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088173 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088185 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088197 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088209 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088211 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
EMA/381816/2017 Page 30/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088223 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088235 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088247 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088250 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088262 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088274 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola menta 20 mg pastiglie BE/H/0104/001 036088286 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
Zerinol Gola ribes nero 20 mg pastiglie BE/H/0103/001 036089050 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
IT
Zerinol Gola ribes nero 20 mg pastiglie BE/H/0103/001 036089062 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
IT
Zerinol Gola ribes nero 20 mg pastiglie BE/H/0103/001 036089098 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
IT
Zerinol Gola ribes nero 20 mg pastiglie BE/H/0103/001 036089112 BOEHRINGER INGELHEIM IT
EMA/381816/2017 Page 31/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
INTERNATIONAL GMBH
Zerinol Gola ribes nero 20 mg pastiglie BE/H/0103/001 036089124 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
IT
Zerinol Gola ribes nero 20 mg pastiglie BE/H/0103/001 036089136 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
IT
Zerinol Gola ribes nero 20 mg pastiglie BE/H/0103/001 036089148 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
IT
Zerinol Gola ribes nero 20 mg pastiglie BE/H/0103/001 036089151 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
IT
Mucosolvan 15 mg gumă orală not available 9085/2016/01 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosolvan 15 mg gumă orală not available 9085/2016/02 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosolvan 15 mg gumă orală not available 9085/2016/04 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucosolvan 15 mg gumă orală not available 9085/2016/03 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucoangin 2.5 mg/actuation oromucosal spray, solution
BE/H/0181/003 135443 SCS BOEHRINGER INGELHEIM COMM.V.
AT
Mucoangin 2.5 mg/actuation oromucosal spray, solution
BE/H/0181/003 48245 SCS BOEHRINGER INGELHEIM COMM.V.
SE
EMA/381816/2017 Page 32/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lizipadol 20 mg pastillas para chupar BE/H/0181/001 75763 BOEHRINGER INGELHEIM ESPANA S.A. ES
Lysopadol ® Lemon 20 mg Lozenges BE/H/0182/001 PA 7/64/1 BOEHRINGER INGELHEIM LTD. IE
Lysopadol® Blackcurrant 20 mg Lozenges
BE/H/0183/001 PA 7/65/1 BOEHRINGER INGELHEIM LTD. IE
Mucoangin Citron 20 mg pastilles BE/H/0181/001 BE423263 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Mucoangin Citroen 20 mg zuigtabletten BE/H/0181/001 BE423263 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Rexambro 20 mg pastilles BE/H/0183/001 BE423297 SCS BOEHRINGER INGELHEIM COMM.V.
BE
Rexambro 20 mg zuigtabletten BE/H/0183/001 BE423297 SCS BOEHRINGER INGELHEIM COMM.V.
BE
MUCOSOLVAN, 15 mg, pastylki miękkie not available 20603 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
PL
MUCOSOLVAN, 30 mg/5 ml, syrop not available 20605 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
PL
Mucoangin Cassis 20 mg, zuigtabletten BE/H/0183/001 RVG 109711 BOEHRINGER INGELHEIM B.V. NL
Mucoangin Citroen 20 mg, zuigtabletten BE/H/0181/001 RVG 109710 BOEHRINGER INGELHEIM B.V. NL
Mucosolvan 30 mg/5 ml Xarope not available 5449145 UNILFARMA LDA. PT
Mucosolvan 30 mg/5 ml Xarope not available 5449152 UNILFARMA LDA. PT
EMA/381816/2017 Page 33/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Surbronc 60 mg/3 g poudre pour solution buvable
not available 0632/02/09/6836 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Mucoangin Citron 20 mg sugtablett BE/H/0182/001 46187 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
SE
Mucoangin Svartvinbär 20 mg sugtablett BE/H/0183/001 46188 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
SE
Mucoangin Cassis, sugetabletter BE/H/0183/001 48951 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
DK
Mucosolvan 75 mg capsule rigide a rilascio prolungato
not available 024428068 BOEHRINGER INGELHEIM ITALIA S.P.A.
IT
SURBRONC EXPECTORANT AMBROXOL SANS SUCRE, solution buvable édulcorée à l’acésulfame potassique et au sorbitol
not available 34009 327 406 3 5 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
Mucoangin Citron, sugetabletter BE/H/0181/001 48883 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
DK
Lysopadol 20 mg τροχίσκοι BE/H/181/001 21500 BOEHRINGER INGELHEIM ELLAS AE CY
Mucosolvan 15 mg Pastilha mole not available 5478227 UNILFARMA LDA. PT
Mucosolvan 30 mg/5 ml sirop not available 828/2008/01 BOEHRINGER INGELHEIM INTERNATIONAL GMBH
RO
Mucoangin Zitrone 20 mg - BE/H/0181/001 1-31241 BOEHRINGER INGELHEIM RCV GMBH & AT
EMA/381816/2017 Page 34/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Lutschtabletten CO KG
Mucosan 30 mg jarabe en sobres not available 77.177 BOEHRINGER INGELHEIM ESPANA S.A. ES
LYSOPAÏNE MAUX DE GORGE AMBROXOL CITRON 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
BE/H/0181/001 34009 222 863 5 8 BOEHRINGER INGELHEIM FRANCE S.A.S
FR
Mucoangin Citron 20 mg pastilles BE/H/0181/001 2012120181 SCS BOEHRINGER INGELHEIM COMM.V.
LU
Lysopadol 20 mg τροχίσκοι BE/H/0181/001 65240 BOEHRINGER INGELHEIM ELLAS AE GR
Mucosolvan® Inhalationslösung 15 mg/2 ml
not available 89.00.02 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Bromax 30 mg comprimidos not available 9568527 FARMA 1000 - PRODUTOS FARMACÊUTICOS, LDA.
PT
Broncoliber not available 9545509 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
Mucosolvan® Hustensaft 30 mg/5 ml Lösung zum Einnehmen
not available 14145.00.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Ambroxol 60 mg Granulat zur Herstellung einer Lösung zum Einnehmen
not available 25689.02.00 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Mucosolvan 60 mg Granulat zur Herstellung einer Lösung zum
not available 15475.00.00 BOEHRINGER INGELHEIM PHARMA DE
EMA/381816/2017 Page 35/35
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Einnehmen GMBH & CO. KG
Deflegmin, 10 mg/dawkę, roztwór doustny Ambroxoli hydrochloridum
DE/H/2226/001 18340 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
PL
Mukambro 10 mg/Sprühstoß Lösung zum Einnehmen
DE/H/2226/001 76710.00.00 CYATHUS EXQUIRERE PHARMAFORSCHUNGSGMBH
DE
Broncoliber 50 mg/ml solução oral DE/H/2226/001 5349352 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
Broncoliber 50 mg/ml solução oral DE/H/2226/001 5349360 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
