Details
Product Name in the RMS: Atozet 10 mg/40 mg Filmtabletten
MR Number: DE/H/3895/003
Date of outcome: 10.09.2014
Type of application | |
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Level 1: Level 2: Level 3: Level 4: Level 5: |
Abridged Additional Strength/Form Fixed Combination Chemical Substance Prescription Only |
Active Substances |
atorvastatin calcium 43,4 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 | 08.01.2021 |
ATC-Code |
C10BA05 atorvastatin and ezetimibe |
CMS Country | Domestic Product Name |
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Austria | Atozet 10 mg/40 mg Filmtabletten |
Belgium | Atozet 10mg/40mg comprimés pelliculés |
Bulgaria | Atozet |
Croatia | Atozet 10 mg/40 mg filmom obložene tablete |
Cyprus | ATOZET FC TABS |
Czech Republic | Zoletorv 10 mg/40 mg potahované tablety |
Denmark | |
France | |
Greece | LIPTRUZET |
Hungary | Liptruzet 10 mg/40 mg filmtabletta |
Iceland | Atozet 10 mg/40 mg Filmuhúðuð tafla |
Ireland | |
Italy | |
Luxembourg | |
Malta | Atozet 10mg/40mg film-coated tablets |
Netherlands | |
Norway | Atozet |
Poland | Atozet |
Portugal | |
Romania | ATOZET 10 mg/40 mg comprimate filmate |
Slovak Republic | ATOZET 10 mg/40 mg |
Spain | |
Sweden | |
United Kingdom |
Documents | |
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PAR: | DE_H_3895_003_PAR.pdf (05.08.2019) |
FinalSPC: | DE_H_3895_003_FinalSPC_1of2.pdf (04.10.2017) |
FinalSPC: | DE_H_3895_003_FinalSPC_2of2.pdf (04.10.2017) |
FinalPL: | DE_H_3895_003_FinalPL_1of2.pdf (09.04.2017) |
FinalPL: | DE_H_3895_003_FinalPL_2of2.pdf (09.04.2017) |
Finalised Product Information: | DE_H_3895_003_FinalPI.pdf (14.09.2020) |