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	Merck Sharp & Dohme Ltd. Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU United Kingdom
RMS	Germany
Date of last change	15.02.2019
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
Portugal
Romania	Atozet
Slovak Republic	ATOZET 10 mg/10 mg
Slovenia
Spain
Sweden
United Kingdom

Documents
PAR:	DE_H_3895_001_PAR.pdf (08.05.2015)
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_1of4.pdf (09.01.2019)
Finalised Product Information:	DE_H_3895_001_FinalPI_2of4.pdf (09.01.2019)
Finalised Product Information:	DE_H_3895_001_FinalPI_3of4.pdf (09.01.2019)
Finalised Product Information:	DE_H_3895_001_FinalPI_4of4.pdf (09.01.2019)