l ist of nationally authorised medicinal products · mucosolvan pre dospelých not available...
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© European Medicines Agency, 2020. Reproduction is authorised provided the source is acknowledged.
14/05/2020 EMA/274516/2020 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: ambroxol
Procedure no.: PSUSA/00000130/201909
List of nationally authorised medicinal products EMA/274516/2020 Page 2/38
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 SANOFI-AVENTIS DEUTSCHLAND GMBH DE Mucosan 6 mg/ml jarabe not available 68.110 SANOFI-AVENTIS, S.A. ES Mucosan 6 mg/ml jarabe not available 68.110 SANOFI-AVENTIS, S.A. ES 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
Mucosolvan Honig-Zitrone 15 mg Lutschpastillen
not available 138451 SANOFI-AVENTIS GMBH OSTERREICH AT
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 033561010 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
Mucosolvan® Injektionslösung 15 mg/2 ml Wirkstoff: Ambroxolhydrochlorid
not available 89.01.01 BOEHRINGER INGELHEIM PHARMA GMBH & CO. KG
DE
Mucosolvan® 1x täglich 75 mg - Retardkapseln
not available 1-18234 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucosolvan® 1x täglich 75 mg - Retardkapseln
not available 1-18234 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucosolvan® 15 mg - Lutschpastillen not available 1-29408 SANOFI-AVENTIS GMBH OSTERREICH AT
List of nationally authorised medicinal products EMA/274516/2020 Page 3/38
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
AMBROSAN 15 mg/5 ml sirup not available 52/0100/00-S PRO.MED.CS PRAHA A.S. SK Ambrospray 10 mg/vpih peroralna raztopina
not available H/07/00162/001 CYATHUS EXQUIRERE PHARMAFORSCHUNGSGMBH
SI
Ambrospray 10 mg/vpih peroralna raztopina
not available H/07/00162/002 CYATHUS EXQUIRERE PHARMAFORSCHUNGSGMBH
SI
Mucosolvan inhalacje 15 mg/2 ml, roztwór do nebulizacji
not available R/1025 SANOFI-AVENTIS SP Z.O.O. PL
Mucibrón 3 mg/ ml solución oral not available 56538 LABORATORIOS NORMON, S.A. ES 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 Mucosolvan® Inhalationslösung 15 mg/2 ml Lösung für einen Vernebler
not available 89.00.02 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan® Inhalationslösung 15 mg/2 ml Lösung für einen Vernebler Wirkstoff: Ambroxolhydrochlorid
not available 89.00.02 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan® Brausetabletten 60 mg Wirkstoff: Ambroxolhydrochlorid
not available 12801.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan® Kindersaft 15 mg/5 ml Lösung zum Einnehmen Wirkstoff: Ambroxolhydrochlorid
not available 89.00.04 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
List of nationally authorised medicinal products EMA/274516/2020 Page 4/38
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 pre dospelých not available 52/0108/02-S SANOFI-AVENTIS SLOVAKIA SRO SK Mucibrón 3 mg/ ml solución oral not available 56538 LABORATORIOS NORMON, S.A. ES Flavamed, oral opløsning DE/H/1443/001 42514 BERLIN-CHEMIE AG DK MUCOSOLVAN LONG EFFECT not available 52/0256/07-S SANOFI-AVENTIS SLOVAKIA SRO SK MUCOSOLVAN LONG EFFECT not available 52/0256/07-S SANOFI-AVENTIS SLOVAKIA SRO SK MUCOSOLVAN LONG EFFECT not available 52/0256/07-S SANOFI-AVENTIS SLOVAKIA SRO SK MUCOSOLVAN LONG EFFECT not available 52/0256/07-S SANOFI-AVENTIS SLOVAKIA SRO SK Mucosolvan® 7,5 mg / 1 ml - Lösung not available 1-17346 SANOFI-AVENTIS GMBH OSTERREICH AT Bromax 120 mg cápsulas de libertação prolongada
not available 9755611 FARMA 1000 - PRODUTOS FARMACÊUTICOS, LDA.
PT
Bromax 6 mg/ml xarope not available 9632711 FARMA 1000 - PRODUTOS FARMACÊUTICOS, LDA.
PT
Bromax 30 mg comprimidos not available 9568527 FARMA 1000 - PRODUTOS FARMACÊUTICOS, LDA.
PT
Mucosolvan® Infusionslösungskonzentrat 1000 mg/50 ml, Konzentrat zur Herstellung einer Infusionslösung
not available 89.00.05 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan® Infusionslösungskonzentrat 1000 mg/50 ml, Konzentrat zur Herstellung einer Infusionslösung
not available 89.00.05 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan® Kindersaft 30 mg/5 ml Lösung zum Einnehmen
not available 25684.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
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- PT
List of nationally authorised medicinal products EMA/274516/2020 Page 5/38
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
MEDICINAL, SA Broncoliber 50 mg/ml solução oral DE/H/2226/001 5349360 TECNIMEDE - SOCIEDADE TÉCNICO-
MEDICINAL, SA PT
Gogolox, 10 mg/rozpylenie, roztwór doustny
DE/H/2226/001 18340 CYATHUS EXQUIRERE PHARMAFORSCHUNGSGMBH
PL
MUCICLAR 15mg/2ml soluzione da nebulizzare
not available 025009097 PIAM FARMACEUTICI SPA IT
MUCICLAR 15mg/5ml sciroppo not available 025009022 PIAM FARMACEUTICI SPA IT MUCICLAR 75mg capsule a rilascio prolungato
not available 025009059 PIAM FARMACEUTICI SPA IT
MUCICLAR 30mg granulato per soluzione orale
not available 025009085 PIAM FARMACEUTICI SPA IT
MUCICLAR 75 mg slow-release capsule
not available MA037/00302 PIAM FARMACEUTICI SPA MT
MUCICLAR 15 mg/5 ml syrup not available MA037/00301 PIAM FARMACEUTICI SPA MT МУКОСОЛВАН 30 mg таблетки not available 9600149 SANOFI BULGARIA EOOD BG МУКОСОЛВАН 30 mg/5ml сироп not available 9600148 SANOFI BULGARIA EOOD BG МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОСОЛВАН 15 mg/5 ml сироп not available 20060026 SANOFI BULGARIA EOOD BG МУКОСОЛВАН МАКС 75 mg капсули с удължено освобождаване, твърди
not available 20060844 SANOFI BULGARIA EOOD BG
МУКОСОЛВАН 15 mg пастили not available 20060843 SANOFI BULGARIA EOOD BG МУКОСОЛВАН МАКС 75 mg капсули с удължено освобождаване, твърди
not available 20060844 SANOFI BULGARIA EOOD BG
MУКОСОЛВАН МАКС 75 mg капсули с удължено освoбождаване, твърди
not available 20060844 SANOFI BULGARIA EOOD BG
List of nationally authorised medicinal products EMA/274516/2020 Page 6/38
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
MУКОСОЛВАН МАКС 75 mg капсули с удължено освoбождаване, твърди
not available 20060844 SANOFI BULGARIA EOOD BG
МУКОСОЛВАН 15 mg пастили not available 20060843 SANOFI BULGARIA EOOD BG МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
List of nationally authorised medicinal products EMA/274516/2020 Page 7/38
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
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
МУКОАНГИН 20 mg таблетки за смучене
not available 20060093 SANOFI BULGARIA EOOD BG
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 FLUIBRON30 mg compresse not available 024596013 CHIESI FARMACEUTICI S.P.A. IT FLUIBRON30 mg compresse not available 024596025 CHIESI FARMACEUTICI S.P.A. IT FLUIBRON Adulti 30 mg granulato per sospensione orale
not available 024596090 CHIESI FARMACEUTICI S.P.A. IT
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 Adulti 30 mg compresse effervescenti
not available 024596189 CHIESI FARMACEUTICI S.P.A. IT
List of nationally authorised medicinal products EMA/274516/2020 Page 8/38
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 Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE MUCOANGIN MENTHE 20 MG PASTILLES
AT/H/0923/001 0330524 SANOFI BELGIUM LU
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088159 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088161 SANOFI S.P.A IT
Zerinol Gola menta 20 mg pastiglie AT/H/0923/001 036088173 SANOFI S.P.A IT ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088185 SANOFI S.P.A IT
Zerinol Gola menta 20 mg pastiglie AT/H/0923/001 036088197 SANOFI S.P.A IT ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088209 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088211 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088223 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088235 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088250 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088262 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088274 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG AT/H/0923/001 036088286 SANOFI S.P.A IT
List of nationally authorised medicinal products EMA/274516/2020 Page 9/38
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
PASTIGLIE ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088247 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088019 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088021 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088033 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088045 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088060 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088146 SANOFI S.P.A IT
Zerinol Gola menta 20 mg pastiglie AT/H/0923/001 036088058 SANOFI S.P.A IT ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088072 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088084 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088096 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088108 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088110 SANOFI S.P.A IT
ZERINOL GOLA MENTA 20 MG AT/H/0923/001 036088122 SANOFI S.P.A IT
List of nationally authorised medicinal products EMA/274516/2020 Page 10/38
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
PASTIGLIE ZERINOL GOLA MENTA 20 MG PASTIGLIE
AT/H/0923/001 036088134 SANOFI S.P.A IT
Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 498 936 7 6 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique
AT/H/0923/001 34009 498 940 4 8 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 498 939 6 6 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 498 937 3 7 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 499 839 5 7 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AT/H/0923/001 34009 499 838 9 6 SANOFI-AVENTIS FRANCE FR
List of nationally authorised medicinal products EMA/274516/2020 Page 11/38
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 MENTHE 20 mg SANS SUCRE, pastille édulcorée au 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.
AT/H/0923/001 34009 499 837 2 8 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 499 836 6 7 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 362 416 1 9 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 362 065 4 0 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 362 064 8 9 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 362 063 1 1 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AT/H/0923/001 34009 362 062 5 0 SANOFI-AVENTIS FRANCE FR
List of nationally authorised medicinal products EMA/274516/2020 Page 12/38
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 MENTHE 20 mg SANS SUCRE, pastille édulcorée au 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.
AT/H/0923/001 34009 362 061 9 9 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 362 060 2 1 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 362 059 4 9 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 362 058 8 8 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 20 mg SANS SUCRE, pastille édulcorée au sorbitol et à la saccharine sodique.
AT/H/0923/001 34009 362 057 1 0 SANOFI-AVENTIS FRANCE FR
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
List of nationally authorised medicinal products EMA/274516/2020 Page 13/38
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 Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
List of nationally authorised medicinal products EMA/274516/2020 Page 14/38
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® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Mint 20 mg - Lutschtabletten
AT/H/0923/001 1-24423 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE
List of nationally authorised medicinal products EMA/274516/2020 Page 15/38
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 Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE
List of nationally authorised medicinal products EMA/274516/2020 Page 16/38
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 AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE426404 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Menthe 20 mg pastilles AT/H/0923/001 BE219177 SANOFI BELGIUM BE Mucoangin Munt 20 mg zuigtabletten AT/H/0923/001 BE219177 SANOFI BELGIUM BE 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 Mucosolvan® 30 mg / 5 ml - Saft not available 1-19598 SANOFI-AVENTIS GMBH OSTERREICH AT Mucosolvan® 30 mg / 5 ml - Saft not available 1-19598 SANOFI-AVENTIS GMBH OSTERREICH AT
List of nationally authorised medicinal products EMA/274516/2020 Page 17/38
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
Mucibrón 3 mg/ ml solución oral not available 56538 LABORATORIOS NORMON, S.A. ES Mucosolvan® Tropfen 30 mg/2 ml Tropfen zum Einnehmen, Lösung
not available 14144.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan® Tropfen 30 mg/2 ml Tropfen zum Einnehmen, Lösung
not available 25685.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosan Retard 75 mg cápsulas de liberación prolongada
not available 60.102 SANOFI-AVENTIS, S.A. ES
Mucosan Retard 75 mg cápsulas de liberación prolongada
not available 60.102 SANOFI-AVENTIS, S.A. ES
MUCOBROXOL® SYRUP not available AA197/00301 MUNDIPHARMA PHARMACEUTICALS LTD MT Mucosolvan® Filmtabletten 60 mg Wirkstoff: Ambroxolhydrochlorid
not available 89.00.07 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan, 30 mg, tabletki not available R/1021 SANOFI-AVENTIS SP Z.O.O. PL Mucosolvan, 30 mg, tabletki not available R/1021 SANOFI-AVENTIS SP Z.O.O. PL AMBROXOL TEVA CONSEIL 0,3 %, solution buvable
not available NL19994 TEVA SANTÉ FR
SURBRONC EXPECTORANT AMBROXOL 30 mg, comprimé sécable
not available 34009 559 554 1 2 SANOFI-AVENTIS FRANCE FR
SURBRONC EXPECTORANT AMBROXOL 30 mg, comprimé sécable
not available 34009 327 405 7 4 SANOFI-AVENTIS FRANCE FR
SURBRONC EXPECTORANT AMBROXOL 30 mg, comprimé sécable
not available 34009 327 404 0 6 SANOFI-AVENTIS FRANCE FR
SURBRONC EXPECTORANT AMBROXOL 30 mg, comprimé sécable
not available 34009 327 403 4 5 SANOFI-AVENTIS FRANCE FR
Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg Lutschtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE
List of nationally authorised medicinal products EMA/274516/2020 Page 18/38
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 Mint 20 mg sugtablett BE/H/0107/001 19952 SANOFI AB SE Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK
List of nationally authorised medicinal products EMA/274516/2020 Page 19/38
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 Mint, sugetabletter BE/H/0107/001 35595 SANOFI-AVENTIS DENMARK A/S DK Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A
SANOFI IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
List of nationally authorised medicinal products EMA/274516/2020 Page 20/38
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
Lysopadol® Mint 20 mg Lozenges BE/H/0107/001 PA 540/186/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg pastilles BE/H/0107/001 BE250171 SANOFI BELGIUM BE Bisolangin 20 mg zuigtabletten BE/H/0107/001 BE250171 SANOFI BELGIUM BE Ambroxolhydrochlorid "Unither DE/H/5058/001 54317 UNITHER PHARMACEUTICALS DK
List of nationally authorised medicinal products EMA/274516/2020 Page 21/38
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
Pharmaceuticals" Ambroxol Hydrochloride Unither Pharmaceuticals 30 mg solution buvable en sachet
DE/H/5058/001 BE485937 UNITHER PHARMACEUTICALS BE
Ambroxol Hydrochloride Unither Pharmaceuticals 30 mg solution buvable en sachet
DE/H/5058/001 2016110269 UNITHER PHARMACEUTICALS LU
Mucosolvan® Hustensaft 30 mg/5 ml Lösung zum Einnehmen
not available 14145.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Ambroxol Unither Pharmaceuticals 30 mg solución oral en sobre
DE/H/5058/001 81573 UNITHER PHARMACEUTICALS ES
MUCOSOLVAN® Σιρόπι 15 mg/5 ml not available 8501 SANOFI-AVENTIS AEBE GR Mucosan pediátrico 3mg/ml jarabe not available 56.156 SANOFI-AVENTIS, S.A. ES Mucosan pediátrico 3 mg/ml jarabe not available 56.156 SANOFI-AVENTIS, S.A. ES MUXOL, solution buvable not available 34009 330 243 4 5 BIOCODEX FR AMBROXOL TEVA CONSEIL 30 mg, comprimé
not available NL19993 TEVA SANTÉ FR
MUCOSOLVAN 30 mg comprimate not available 7694/2015/01 SANOFI ROMANIA SRL RO MUCOSOLVAN MAX 75 mg capsule cu eliberare prelungită
not available 7323/2015/04 SANOFI ROMANIA SRL RO
MUCOSOLVAN MAX 75 mg capsule cu eliberare prelungită
not available 7323/2015/03 SANOFI ROMANIA SRL RO
MUCOSOLVAN MAX 75 mg capsule cu eliberare prelungită
not available 7323/2015/02 SANOFI ROMANIA SRL RO
MUCOSOLVAN MAX 75 mg capsule cu eliberare prelungită
not available 7323/2015/01 SANOFI ROMANIA SRL RO
MUCOSOLVAN 30 MG/5 ML, SIROP not available 828/2008/01 SANOFI ROMANIA SRL RO
List of nationally authorised medicinal products EMA/274516/2020 Page 22/38
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 Junior 15 mg/5 ml, sirop not available 870/2008/01 SANOFI ROMANIA SRL RO MUCOSOLVAN 15 mg gumă orală not available 9085/2016/03 SANOFI ROMANIA SRL RO MUCOSOLVAN 15 mg gumă orală not available 9085/2016/04 SANOFI ROMANIA SRL RO MUCOSOLVAN 15 mg gumă orală not available 9085/2016/02 SANOFI ROMANIA SRL RO MUCOSOLVAN 15 mg gumă orală not available 9085/2016/01 SANOFI ROMANIA SRL RO Mucosolvan 15 mg pastiglie gommose – gusto Miele e Limone
not available 024428308 SANOFI S.P.A IT
AMBROXOLO SANOFI 75 mg capsule rigide a rilascio prolungato.
not available 046579013 SANOFI S.P.A IT
Mucosolvan Perlonguets 75 mg Cápsulas de libertação prolongada
not available 8631119 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Mucosolvan Perlonguets 75 mg Cápsulas de libertação prolongada
not available 5490248 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Mucosolvan 6 mg/ml Xarope not available 3245586 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Mucosolvan 6 mg/ml Xarope not available 3245685 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Mucosolvan 6 mg/ml Xarope not available 8574913 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Mucosolvan Tablety 30 mg not available 52/0243/02-S SANOFI-AVENTIS SLOVAKIA SRO SK Mucosolvan Tablety 30 mg not available 52/0243/02-S SANOFI-AVENTIS SLOVAKIA SRO SK Mucibrón 3 mg/ ml solución oral not available 56538 LABORATORIOS NORMON, S.A. ES Flavamed, brusetabletter DE/H/1567/001 43072 BERLIN-CHEMIE AG DK Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE MUCOANGIN CASSIS 20 mg PASTILLES
AT/H/0922/001 0632/06/08/8966 SANOFI BELGIUM LU
List of nationally authorised medicinal products EMA/274516/2020 Page 23/38
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
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0922/001 34009 392 596 8 0 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0922/001 34009 392 595 1 2 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0922/001 34009 392 594 5 1 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0922/001 34009 392 593 9 0 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0922/001 34009 392 592 2 2 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0922/001 34009 392 591 6 1 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0922/001 34009 392 589 1 1 SANOFI-AVENTIS FRANCE FR
List of nationally authorised medicinal products EMA/274516/2020 Page 24/38
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
LYSOPAÏNE MAUX DE GORGE AMBROXOL CASSIS 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0922/001 34009 392 588 5 0 SANOFI-AVENTIS FRANCE FR
ZERINOL GOLA RIBES NERO 20 MG PASTIGLIE
AT/H/0922/001 036089151 SANOFI S.P.A IT
ZERINOL GOLA RIBES NERO 20 MG PASTIGLIE
AT/H/0922/001 036089062 SANOFI S.P.A IT
Zerinol Gola ribes nero 20 mg pastiglie
AT/H/0922/001 036089112 SANOFI S.P.A IT
ZERINOL GOLA RIBES NERO 20 MG PASTIGLIE
AT/H/0922/001 036089098 SANOFI S.P.A IT
ZERINOL GOLA RIBES NERO 20 MG PASTIGLIE
AT/H/0922/001 036089148 SANOFI S.P.A IT
ZERINOL GOLA RIBES NERO 20 MG PASTIGLIE
AT/H/0922/001 036089050 SANOFI S.P.A IT
ZERINOL GOLA RIBES NERO 20 MG PASTIGLIE
AT/H/0922/001 036089136 SANOFI S.P.A IT
ZERINOL GOLA RIBES NERO 20 MG PASTIGLIE
AT/H/0922/001 036089124 SANOFI S.P.A IT
Mucoangin® Johannisbeere 20 mg - Lutschtabletten
AT/H/0922/001 1-24422 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Johannisbeere 20 mg - Lutschtabletten
AT/H/0922/001 1-24422 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Johannisbeere 20 mg - Lutschtabletten
AT/H/0922/001 1-24422 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Johannisbeere 20 mg - Lutschtabletten
AT/H/0922/001 1-24422 SANOFI-AVENTIS GMBH OSTERREICH AT
List of nationally authorised medicinal products EMA/274516/2020 Page 25/38
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® Johannisbeere 20 mg - Lutschtabletten
AT/H/0922/001 1-24422 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Johannisbeere 20 mg - Lutschtabletten
AT/H/0922/001 1-24422 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Johannisbeere 20 mg - Lutschtabletten
AT/H/0922/001 1-24422 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin® Johannisbeere 20 mg - Lutschtabletten
AT/H/0922/001 1-24422 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg pastilles AT/H/0922/001 BE219064 SANOFI BELGIUM BE Mucoangin Cassis 20 mg zuigtabletten AT/H/0922/001 BE219064 SANOFI BELGIUM BE SECRETIL“15mg/5 ml sciroppo” not available 025025053 I.B.N. SAVIO S.R.L. IT
List of nationally authorised medicinal products EMA/274516/2020 Page 26/38
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
flacone da 200 ml SECRETIL “15 mg/2 ml soluzione da nebulizzare” flacone da 100 ml
not available 025025065 I.B.N. SAVIO S.R.L. IT
SECRETIL “60 mg granulato per soluzione orale” 20 bustine da 60 mg
not available 025025089 I.B.N. SAVIO S.R.L. IT
SECRETIL “30 mg/4 ml soluzione da nebulizzare” 20 contenitori monodose da 4 ml
not available 025025127 I.B.N. SAVIO S.R.L. IT
SECRETIL “15 mg/2 ml soluzione sterile da nebulizzare” 6 fiale da 2 ml
not available 025025077 I.B.N. SAVIO S.R.L. IT
AMBROXOL SFIP 30 mg, solution buvable édulcorée à l’acésulfame potassique et au sorbitol en sachet
not available 34009 301 509 8 6 SFIP SOCIÉTÉ FINANCIÉRE D'INVESTISSEMENTS PHARMACEUTIQUES
FR
Mucosolvan® Tabletten 30 mg Wirkstoff: Ambroxolhydrochlorid
not available 89.01.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Ambroxol 1A Pharma 7,5 mg/ml - Lösung
not available 1-24729 1A PHARMA GMBH AT
Surbronc 60 mg Filmtabletten not available BE141312 SANOFI BELGIUM BE Surbronc 60 mg comprimés pelliculés not available BE141312 SANOFI BELGIUM BE Surbronc 60 mg filmomhulde tabletten not available BE141312 SANOFI BELGIUM BE Surbronc 30 mg/5 ml Sirup not available BE141136 SANOFI BELGIUM BE Surbronc 30 mg/5 ml sirop not available BE141136 SANOFI BELGIUM BE Surbronc 30 mg/5 ml siroop not available BE141136 SANOFI BELGIUM BE Surbronc 60 mg filmomhulde tabletten not available BE141312 SANOFI BELGIUM BE Surbronc 60 mg comprimés pelliculés not available BE141312 SANOFI BELGIUM BE Surbronc 60 mg filmomhulde tabletten not available BE141312 SANOFI BELGIUM BE Surbronc 60 mg comprimés pelliculés not available BE141312 SANOFI BELGIUM BE
List of nationally authorised medicinal products EMA/274516/2020 Page 27/38
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 30 mg/5 ml siroop not available BE141136 SANOFI BELGIUM BE Surbronc 30 mg/5 ml sirop not available BE141136 SANOFI BELGIUM BE MUCOSOLVAN® not available 8501 SANOFI-AVENTIS AEBE GR MUCOSOLVAN® Σιρόπι 15 mg/5 ml not available 8501 SANOFI-AVENTIS AEBE GR MUCOSOLVAN® not available 8501 SANOFI-AVENTIS AEBE GR Mucosolvan® Ενέσιμο διάλυμα 15 mg/2 ml
not available 8501 SANOFI-AVENTIS AEBE GR
Broncoliber 6 mg/ml xarope not available 9545517 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
Broncoliber 30 mg comprimidos not available 9545418 TECNIMEDE - SOCIEDADE TÉCNICO-MEDICINAL, SA
PT
Ambroxol AbZ Hustensaft 15 mg/5 ml Lösung zum Einnehmen
not available 38565.00.00 ABZ-PHARMA GMBH DE
FLUIBRON 15 mg/5 ml syrup (0.3% w/v)
not available 12668 CHIESI HELLAS A.E.B.E. CY
Mucosan® 15 mg - Ampullen not available 1-17345 SANOFI-AVENTIS GMBH OSTERREICH AT MUCOBROXOL® SYRUP not available 19999 MUNDIPHARMA PHARMACEUTICALS LTD CY Surbronc 60 mg Filmtabletten not available 0632/02/09/6835 SANOFI BELGIUM LU SURBRONC 60 mg comprimés pelliculés
not available 0632/02/09/6835 SANOFI BELGIUM LU
Surbronc 30 mg/5 ml Sirup not available 0632/02/09/6837 SANOFI BELGIUM LU MUCOSOLVAN 30 MG COMPRESSE not available 024428017 SANOFI S.P.A IT Motosol 7,5 mg/ml solución inyectable not available 56.155 SANOFI-AVENTIS, S.A. ES Mucosolvan, 30 mg/5 ml, syrop not available R/1022 BOEHRINGER INGELHEIM
INTERNATIONAL GMBH PL
Mucoangin 20 mg szopogató tabletta not available OGYI-T-9384/04 SANOFI-AVENTIS ZRT HU Mucoangin 20 mg szopogató tabletta not available OGYI-T-9384/01 SANOFI-AVENTIS ZRT HU
List of nationally authorised medicinal products EMA/274516/2020 Page 28/38
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-9384/05 SANOFI-AVENTIS ZRT HU Mucosolvan Tablety 30 mg not available 52/0243/02-S SANOFI-AVENTIS SLOVAKIA SRO SK MUCOSOLVAN LONG EFFECT not available 52/0256/07-S SANOFI-AVENTIS SLOVAKIA SRO SK Mucosolvan 15 mg Měkké pastilky not available 52/635/09-C SANOFI-AVENTIS SRO CZ Mucosolvan 15 mg mäkké pastilky not available 52/0559/08-S SANOFI-AVENTIS SLOVAKIA SRO SK Mucosolvan pre dospelých not available 52/0108/02-S SANOFI-AVENTIS SLOVAKIA SRO SK Mucosolvan 30 mg tablete not available HR-H-896955635-01 SANOFI-AVENTIS CROATIA D.O.O. HR Mucosolvan 75 mg kapsule s produljenim oslobađanjem
not available HR-H-472120462-01 SANOFI-AVENTIS CROATIA D.O.O. HR
Mucosolvan 75 mg kapsule s produljenim oslobađanjem
not available HR-H-472120462 SANOFI-AVENTIS CROATIA D.O.O. HR
MUCOSOLVAN MINI, 15 mg/5 ml, syrop
not available 18296 SANOFI-AVENTIS SP Z.O.O. PL
Mucoangin, 20 mg, tabletki do ssania not available 9766 SANOFI-AVENTIS SP Z.O.O. PL SURFACTAL 1g/50 ml soluzione per infusione
not available 026751026 SANOFI S.P.A IT
MUCOSOLVAN 60 MG GRANULATO PER SOLUZIONE ORALE
not available 024428169 SANOFI S.P.A IT
MUCOSOLVAN 15 mg/2 ml soluzione da nebulizzare
not available 024428043 SANOFI S.P.A IT
MUCOSOLVAN 7,5 MG/ML SOLUZIONE DA NEBULIZZARE
not available 024428144 SANOFI S.P.A IT
MUCOSOLVAN bambini 30 mg supposte.
not available 024428082 SANOFI S.P.A IT
MUCOSOLVAN 15 mg/5 ml sciroppo– gusto lampone
not available 024428132 SANOFI S.P.A IT
MUCOSOLVAN 15 MG PASTIGLIE not available 024428195 SANOFI S.P.A IT
List of nationally authorised medicinal products EMA/274516/2020 Page 29/38
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
GOMMOSE MUCOSOLVAN 15 MG PASTIGLIE GOMMOSE
not available 024428219 SANOFI S.P.A IT
Mucosolvan 30 mg Comprimidos not available 9574715 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Mucosolvan 15 mg/2 ml solução injetável
not available 8574608 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Mucosolvan 15 mg Pastilha mole not available 5478227 SANOFI - PRODUTOS FARMACEUTICOS LDA
PT
Motosol Retard 75 mg cápsulas de liberación prolongada
not available 60.103 SANOFI-AVENTIS, S.A. ES
Mucosan 60 mg polvo para solución oral
not available 59.170 SANOFI-AVENTIS, S.A. ES
Mucosolvan, 30 mg/5 ml, syrop not available R/1022 SANOFI-AVENTIS SP Z.O.O. PL MUCOSOLVAN® not available 40921/11 SANOFI-AVENTIS AEBE GR MUCOSOLVAN® not available 8501 SANOFI-AVENTIS AEBE GR MUCOSOLVAN® not available 40920/11 SANOFI-AVENTIS AEBE GR MUCOSOLVAN® Σιρόπι 15 mg/5 ml not available 8501 SANOFI-AVENTIS AEBE GR MUCOSOLVAN® not available 8501 SANOFI-AVENTIS AEBE GR MUCOSOLVAN® not available 19781 SANOFI-AVENTIS AEBE CY MUCOSOLVAN® not available 20696 SANOFI-AVENTIS AEBE CY MUCOSOLVAN® Σιρόπι 15 mg/5 ml not available 11682 SANOFI-AVENTIS AEBE CY MUCOSOLVAN® not available 21127 SANOFI-AVENTIS AEBE CY Mucosolvan® Ενέσιμο διάλυμα 15 mg/2 ml
not available 11681 SANOFI-AVENTIS AEBE CY
Motosol Retard 75 mg cápsulas de liberación prolongada
not available 60.103 SANOFI-AVENTIS, S.A. ES
List of nationally authorised medicinal products EMA/274516/2020 Page 30/38
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® not available 40920/11 SANOFI-AVENTIS AEBE GR Mucoangin, 20 mg, tabletki do ssania not available 9766 SANOFI-AVENTIS SP Z.O.O. PL Mucoangin, 20 mg, tabletki do ssania not available 9766 SANOFI-AVENTIS SP Z.O.O. PL Mucoangin, 20 mg, tabletki do ssania not available 9766 SANOFI-AVENTIS SP Z.O.O. PL Mucoangin, 20 mg, tabletki do ssania not available 9766 SANOFI-AVENTIS SP Z.O.O. PL Mucoangin, 20 mg, tabletki do ssania not available 9766 SANOFI-AVENTIS SP Z.O.O. PL Mucosolvan, 30 mg/5 ml, syrop not available R/1022 SANOFI-AVENTIS SP Z.O.O. PL MUCOSOLVAN MINI, 15 mg/5 ml, syrop
not available 18296 SANOFI-AVENTIS SP Z.O.O. PL
Mucosolvan Tablety 30 mg not available 52/0243/02-S SANOFI-AVENTIS SLOVAKIA SRO SK MUCOSOLVAN LONG EFFECT not available 52/0256/07-S SANOFI-AVENTIS SLOVAKIA SRO SK MUCOSOLVAN LONG EFFECT not available 52/0256/07-S SANOFI-AVENTIS SLOVAKIA SRO SK MUCOSOLVAN LONG EFFECT not available 52/0256/07-S SANOFI-AVENTIS SLOVAKIA SRO SK Mucosolvan 15 mg mäkké pastilky not available 52/0559/08-S SANOFI-AVENTIS SLOVAKIA SRO SK Mucosolvan 15 mg mäkké pastilky not available 52/0559/08-S SANOFI-AVENTIS SLOVAKIA SRO SK MUCOSOLVAN® Κόμμι από στόματος 15MG/GUM
not available 40921/11 SANOFI-AVENTIS AEBE GR
MUCOSOLVAN® Κόμμι από στόματος 15MG/GUM
not available 40921/11 SANOFI-AVENTIS AEBE GR
Mucosolvan® Ενέσιμο διάλυμα 15 mg/2 ml
not available 8501 SANOFI-AVENTIS AEBE GR
AMBROXOL SFIP 30 mg, solution buvable édulcorée à l’acésulfame potassique et au sorbitol en sachet
not available 34009 301 509 8 6 SFIP SOCIÉTÉ FINANCIÉRE D'INVESTISSEMENTS PHARMACEUTIQUES
FR
SURBRONC EXPECTORANT AMBROXOL SANS SUCRE, solution buvable édulcorée à l’acésulfame potassique et
not available 34009 327 406 3 5 SANOFI-AVENTIS FRANCE FR
List of nationally authorised medicinal products EMA/274516/2020 Page 31/38
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
au sorbitol SURBRONC EXPECTORANT AMBROXOL SANS SUCRE, solution buvable édulcorée à l’acésulfame potassique et au sorbitol
not available 34009 327 409 2 5 SANOFI-AVENTIS FRANCE FR
Clarvivo 20 mg sugetabletter med mintsmak
not available 14-10289 KARO PHARMA AS NO
Clarvivo 20 mg sugetabletter med lakrissmak
not available 14-10290 KARO PHARMA AS NO
Mucosolvan® Hustensaft 30 mg/5 ml Lösung zum Einnehmen
not available 14145.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
MUCOANGIN CITRON 20 MG PASTILLES
AT/H/0924/001 2012120181 SANOFI BELGIUM LU
Mucoangin Citron 20 mg pastilles AT/H/0924/001 BE423263 SANOFI BELGIUM BE Mucoangin Citroen 20 mg zuigtabletten
AT/H/0924/001 BE423263 SANOFI BELGIUM BE
ZERINOL GOLA 20 MG PASTIGLIE AT/H/0924/001 041239272 SANOFI S.P.A IT ZERINOL GOLA 20 MG PASTIGLIE AT/H/0924/001 041239260 SANOFI S.P.A IT ZERINOL GOLA 20 MG PASTIGLIE AT/H/0924/001 041239245 SANOFI S.P.A IT ZERINOL GOLA 20 MG PASTIGLIE AT/H/0924/001 041239221 SANOFI S.P.A IT ZERINOL GOLA 20 MG PASTIGLIE AT/H/0924/001 041239219 SANOFI S.P.A IT ZERINOL GOLA 20 MG PASTIGLIE AT/H/0924/001 041239195 SANOFI S.P.A IT ZERINOL GOLA 20 MG PASTIGLIE AT/H/0924/001 041239171 SANOFI S.P.A IT LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 17,86 mg/ml SANS SUCRE, solution pour pulvérisation buccale édulcorée au
AT/H/0924/002 34009 278 529 3 0 SANOFI-AVENTIS FRANCE FR
List of nationally authorised medicinal products EMA/274516/2020 Page 32/38
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
sucralose LYSOPAÏNE MAUX DE GORGE AMBROXOL MENTHE 17,86 mg/ml SANS SUCRE, solution pour pulvérisation buccale édulcorée au sucralose
AT/H/0924/002 34009 300 110 8 9 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CITRON 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0924/001 34009 222 863 5 8 SANOFI-AVENTIS FRANCE FR
LYSOPAÏNE MAUX DE GORGE AMBROXOL CITRON 20 mg SANS SUCRE, pastille édulcorée au sorbitol et au sucralose
AT/H/0924/001 34009 222 861 2 9 SANOFI-AVENTIS FRANCE FR
ZERINOL GOLA 2,5 MG/EROGAZIONE SPRAY PER MUCOSA ORALE, SOLUZIONE
AT/H/0924/002 041239296 SANOFI S.P.A IT
ZERINOL GOLA 2,5 MG/EROGAZIONE SPRAY PER MUCOSA ORALE, SOLUZIONE
AT/H/0924/002 041239308 SANOFI S.P.A IT
Lysopadol 17.86 mg/ml Oromucosal Spray, Solution
AT/H/0924/002 PA 540/186/2 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lizipaina ambroxol 17,86 mg/ ml solución para pulverización bucal
AT/H/0924/002 78669 SANOFI-AVENTIS, S.A. ES
Lizipaina ambroxol 20 mg pastillas para chupar
AT/H/0924/001 75763 SANOFI-AVENTIS, S.A. ES
Mucoangin Zitrone 20 mg - Lutschtabletten
AT/H/0924/001 1-31241 SANOFI-AVENTIS GMBH OSTERREICH AT
List of nationally authorised medicinal products EMA/274516/2020 Page 33/38
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
Lysopadol 2,5 mg/ψεκασμό στοματικό εκνέφωμα, διάλυμα
AT/H/0924/002 70850 SANOFI-AVENTIS AEBE GR
Lysopadol 20 mg τροχίσκοι AT/H/0924/001 65240 SANOFI-AVENTIS AEBE GR Mucoangin 17,86 mg/ml - Spray zur Anwendung in der Mundhöhle
AT/H/0924/002 135443 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin, mundhulespray, opløsning AT/H/0924/002 51095 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Citron 20 mg sugtablett AT/H/0924/001 46187 SANOFI AB SE Mucoangin Citron, sugetabletter AT/H/0924/001 48883 SANOFI-AVENTIS DENMARK A/S DK Lysopadol 2,5 mg/ψεκασμό στοματικό εκνέφωμα, διάλυμα
AT/H/0924/002 22023 SANOFI-AVENTIS AEBE CY
Lysopadol 20 mg Tροχίσκοι AT/H/0924/001 21500 SANOFI-AVENTIS AEBE CY Lysopadol 20 mg Tροχίσκοι AT/H/0924/001 21500 SANOFI-AVENTIS AEBE CY Lysopadol 20 mg Tροχίσκοι AT/H/0924/001 21500 SANOFI-AVENTIS AEBE CY Lysopadol 20 mg Tροχίσκοι AT/H/0924/001 21500 SANOFI-AVENTIS AEBE CY Lysopadol 20 mg Tροχίσκοι AT/H/0924/001 21500 SANOFI-AVENTIS AEBE CY Lysopadol 20 mg Tροχίσκοι AT/H/0924/001 21500 SANOFI-AVENTIS AEBE CY Lysopadol 20 mg Tροχίσκοι AT/H/0924/001 21500 SANOFI-AVENTIS AEBE CY Mucoangin Citron, sugetabletter AT/H/0924/001 48883 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Citron, sugetabletter AT/H/0924/001 48883 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Citron, sugetabletter AT/H/0924/001 48883 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Citron, sugetabletter AT/H/0924/001 48883 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Citron, sugetabletter AT/H/0924/001 48883 SANOFI-AVENTIS DENMARK A/S DK Mucoangin Citron, sugetabletter AT/H/0924/001 48883 SANOFI-AVENTIS DENMARK A/S DK Mucoangin, mundhulespray, opløsning AT/H/0924/002 51095 SANOFI-AVENTIS DENMARK A/S DK Lysopadol ® Lemon 20 mg Lozenges AT/H/0924/001 PA 540/187/1 SANOFI-AVENTIS IRELAND LTD. T/A
SANOFI IE
Lysopadol ® Lemon 20 mg Lozenges AT/H/0924/001 PA 540/187/1 SANOFI-AVENTIS IRELAND LTD. T/A IE
List of nationally authorised medicinal products EMA/274516/2020 Page 34/38
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
SANOFI Lysopadol ® Lemon 20 mg Lozenges AT/H/0924/001 PA 540/187/1 SANOFI-AVENTIS IRELAND LTD. T/A
SANOFI IE
Lysopadol ® Lemon 20 mg Lozenges AT/H/0924/001 PA 540/187/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol ® Lemon 20 mg Lozenges AT/H/0924/001 PA 540/187/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol ® Lemon 20 mg Lozenges AT/H/0924/001 PA 540/187/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Lysopadol ® Lemon 20 mg Lozenges AT/H/0924/001 PA 540/187/1 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
Mucoangin Zitrone 20 mg - Lutschtabletten
AT/H/0924/001 1-31241 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin Zitrone 20 mg - Lutschtabletten
AT/H/0924/001 1-31241 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin Zitrone 20 mg - Lutschtabletten
AT/H/0924/001 1-31241 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin Zitrone 20 mg - Lutschtabletten
AT/H/0924/001 1-31241 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin Zitrone 20 mg - Lutschtabletten
AT/H/0924/001 1-31241 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin Zitrone 20 mg - Lutschtabletten
AT/H/0924/001 1-31241 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucoangin 17,86 mg/ml - Spray zur Anwendung in der Mundhöhle
AT/H/0924/002 135443 SANOFI-AVENTIS GMBH OSTERREICH AT
Lizipaina ambroxol 20 mg pastillas para chupar
AT/H/0924/001 75763 SANOFI-AVENTIS, S.A. ES
List of nationally authorised medicinal products EMA/274516/2020 Page 35/38
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
Lizipaina ambroxol 20 mg pastillas para chupar
AT/H/0924/001 75763 SANOFI-AVENTIS, S.A. ES
Lizipaina ambroxol 20 mg pastillas para chupar
AT/H/0924/001 75763 SANOFI-AVENTIS, S.A. ES
Lizipaina ambroxol 20 mg pastillas para chupar
AT/H/0924/001 75763 SANOFI-AVENTIS, S.A. ES
Lizipaina ambroxol 20 mg pastillas para chupar
AT/H/0924/001 75763 SANOFI-AVENTIS, S.A. ES
Lizipaina ambroxol 20 mg pastillas para chupar
AT/H/0924/001 75763 SANOFI-AVENTIS, S.A. ES
Lizipaina ambroxol 20 mg pastillas para chupar
AT/H/0924/001 75763 SANOFI-AVENTIS, S.A. ES
Lysopadol 17.86 mg/ml Oromucosal Spray, Solution
AT/H/0924/002 PA 540/186/2 SANOFI-AVENTIS IRELAND LTD. T/A SANOFI
IE
MUCOANGIN AT/H/0924/002 48245 SANOFI AB SE MUCOANGIN AT/H/0924/002 48245 SANOFI AB SE Lizipaina ambroxol 17,86 mg/ ml solución para pulverización bucal
AT/H/0924/002 78669 SANOFI-AVENTIS, S.A. ES
Lysopadol 20 mg τροχίσκοι AT/H/0924/001 65240 SANOFI-AVENTIS AEBE GR Lysopadol 20 mg τροχίσκοι AT/H/0924/001 65240 SANOFI-AVENTIS AEBE GR Lysopadol 20 mg τροχίσκοι AT/H/0924/001 65240 SANOFI-AVENTIS AEBE GR Lysopadol 20 mg τροχίσκοι AT/H/0924/001 65240 SANOFI-AVENTIS AEBE GR Lysopadol 20 mg τροχίσκοι AT/H/0924/001 65240 SANOFI-AVENTIS AEBE GR Lysopadol 20 mg τροχίσκοι AT/H/0924/001 65240 SANOFI-AVENTIS AEBE GR Lysopadol 2,5 mg/ψεκασμό στοματικό εκνέφωμα, διάλυμα
AT/H/0924/002 70850 SANOFI-AVENTIS AEBE GR
Mucoangin Citroen 20 mg AT/H/0924/001 BE423263 SANOFI BELGIUM BE
List of nationally authorised medicinal products EMA/274516/2020 Page 36/38
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
zuigtabletten Mucoangin Citron 20 mg pastilles AT/H/0924/001 BE423263 SANOFI BELGIUM BE Mucoangin Citroen 20 mg zuigtabletten
AT/H/0924/001 BE423263 SANOFI BELGIUM BE
Mucoangin Citron 20 mg pastilles AT/H/0924/001 BE423263 SANOFI BELGIUM BE Mucoangin Citroen 20 mg zuigtabletten
AT/H/0924/001 BE423263 SANOFI BELGIUM BE
Mucoangin Citron 20 mg pastilles AT/H/0924/001 BE423263 SANOFI BELGIUM BE Mucoangin Citron 20 mg pastilles AT/H/0924/001 BE423263 SANOFI BELGIUM BE Mucoangin Citroen 20 mg zuigtabletten
AT/H/0924/001 BE423263 SANOFI BELGIUM BE
Mucoangin Citron 20 mg pastilles AT/H/0924/001 BE423263 SANOFI BELGIUM BE Mucoangin Citroen 20 mg zuigtabletten
AT/H/0924/001 BE423263 SANOFI BELGIUM BE
Mucoangin gegen Halsschmerzen Zitrone
AT/H/0924/001 85171.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucoangin® gegen Halsschmerzen Zitrone 20 mg Lutschtabletten
AT/H/0924/001 85171.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucoangin gegen Halsschmerzen Zitrone
AT/H/0924/001 85171.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucoangin gegen Halsschmerzen Zitrone
AT/H/0924/001 85171.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucibrón 3 mg/ ml solución oral not available 56538 LABORATORIOS NORMON, S.A. ES MUCOSOLVAN 15 mg/5 ml sciroppo - gusto frutti di bosco
not available 024428272 SANOFI S.P.A IT
MUCOSOLVAN 30 mg/5 ml sciroppo not available 024428233 SANOFI S.P.A IT MUCOSOLVAN 30 mg/5 ml sciroppo not available 024428258 SANOFI S.P.A IT
List of nationally authorised medicinal products EMA/274516/2020 Page 37/38
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
Ambrosan 15 mg/5 ml sirup not available 52/703/99-C PRO.MED.CS PRAHA A.S. CZ CORYFIN ESPETTORANTE 3mg/ml sciroppo
not available 025311022 LABORATORIO FARMACEUTICO S.I.T. S.R.L.
IT
Clarvivo mint 20 mg sugtablett not available 51720 KARO PHARMA AS SE Clarvivo lakrits 20 mg sugtablett not available 51721 KARO PHARMA AS SE Ambroxol 60 mg Granulat zur Herstellung einer Lösung zum Einnehmen Wirkstoff: Ambroxolhydrochlorid
not available 25689.02.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan 60 mg Granulat zur Herstellung einer Lösung zum Einnehmen Wirkstoff: Ambroxolhydrochlorid
not available 15475.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan® Lutschpastillen 15 mg Wirkstoff: Ambroxolhydrochlorid
not available 17548.00.00 SANOFI-AVENTIS DEUTSCHLAND GMBH DE
Mucosolvan Max, 75 mg,Kapsułki o przedłużonym uwalnianiu, twarde
not available 23053 SANOFI-AVENTIS SP Z.O.O. PL
MUCOSOLVAN MAX, 75 mg, kapsułki o przedłużonym uwalnianiu, twarde
not available 23053 SANOFI-AVENTIS SP Z.O.O. PL
Mucosolvan Roztok k perorálnímu podání a k inhalaci
not available 52/121/81-C SANOFI-AVENTIS SRO CZ
Mucosolvan 15 mg Měkké pastilky not available 52/635/09-C SANOFI-AVENTIS SRO CZ Mucosolvan pro dospělé 30 mg/5 ml sirup
not available 52/231/05-C SANOFI-AVENTIS SRO CZ
Mucosolvan junior Sirup not available 52/123/81-C SANOFI-AVENTIS SRO CZ Mucosolvan Tablety not available 52/122/81-C SANOFI-AVENTIS SRO CZ MUCOSOLVAN long effect Tvrdé not available 52/141/91-C SANOFI-AVENTIS SRO CZ
List of nationally authorised medicinal products EMA/274516/2020 Page 38/38
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
tobolky s prodlouženým uvolňováním Mucosolvan® 15 mg / 5 ml - Saft für Kinder
not available 1-17347 SANOFI-AVENTIS GMBH OSTERREICH AT
Mucosolvan® 15 mg / 5 ml - Saft für Kinder
not available 1-17347 SANOFI-AVENTIS GMBH OSTERREICH AT
MUCOSOLVAN® not available 40920/11 SANOFI-AVENTIS AEBE GR MUCOSOLVAN® not available 40920/11 SANOFI-AVENTIS AEBE GR Broncoliber 3 mg/ml xarope not available 9545509 TECNIMEDE - SOCIEDADE TÉCNICO-
MEDICINAL, SA PT
MUCOSAN 30 MG COMPRIMIDOS not available 56.154 SANOFI-AVENTIS, S.A. ES Motosol 3mg/ml jarabe not available 56.357 SANOFI-AVENTIS, S.A. ES Motosol 3 mg/ml jarabe not available 56.357 SANOFI-AVENTIS, S.A. ES MUCOSOLVAN 75 MG CAPSULE RIGIDE A RILASCIO PROLUNGATO
not available 024428068 SANOFI S.P.A IT