Details
Product Name in the RMS: Atozet 10 mg/10 mg Filmtabletten
MR Number: DE/H/3895/001
Date of outcome: 10.09.2014
Type of application | |
---|---|
Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Initial Application Fixed Combination Chemical Substance Prescription Only |
Active Substances |
atorvastatin calcium 10,9 mg ezetimibe 10 mg |
Form | Film coated tablet |
MA Holder in the RMS |
MSD Sharp & Dohme GmbH Lindenplatz 1 85540 Haar Germany |
RMS | Germany |
Date of last change | 16.01.2021 |
ATC-Code |
C10BA05 atorvastatin and ezetimibe |
CMS Country | Domestic Product Name |
---|---|
Austria | Atozet 10 mg/10 mg Filmtabletten |
Belgium | Atozet 10mg/10mg comprimés pelliculés |
Bulgaria | Atozet |
Croatia | Atozet 10 mg/10 mg filmom obložene tablete |
Cyprus | ATOZET FC TABS |
Czech Republic | Zoletorv 10 mg/10 mg potahované tablety |
Denmark | |
France | |
Greece | LIPTRUZET |
Hungary | Liptruzet 10 mg/10 mg filmtabletta |
Iceland | Atozet 10 mg/10 mg Filmuhúðuð tafla |
Ireland | |
Italy | |
Luxembourg | |
Malta | Atozet 10mg/10mg film-coated tablets |
Netherlands | |
Norway | Atozet |
Poland | Atozet |
Portugal | |
Romania | ATOZET 10 mg/10 mg comprimate filmate |
Slovak Republic | ATOZET 10 mg/10 mg |
Sweden | |
United Kingdom |
Documents | |
---|---|
PAR: | DE_H_3895_001_PAR.pdf (05.08.2019) |
FinalSPC: | DE_H_3895_001_FinalSPC_1of2.pdf (04.10.2017) |
FinalSPC: | DE_H_3895_001_FinalSPC_2of2.pdf (04.10.2017) |
FinalPL: | DE_H_3895_001_FinalPL_1of2.pdf (09.04.2017) |
FinalPL: | DE_H_3895_001_FinalPL_2of2.pdf (09.04.2017) |
Finalised Product Information: | DE_H_3895_001_FinalPI.pdf (14.09.2020) |