Details

Product Name in the RMS: Atorvastatine Aurobindo 40 mg filmomhulde tabletten

MR Number: NL/H/2982/003
Date of outcome: 03.07.2014

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Additional Strength/Form Generic Chemical Substance Prescription Only
Active Substances	atorvastatin calcium trihydrate 43,3 mg
Form	Film coated tablet
MA Holder in the RMS	Aurobindo Pharma B.V. Baarnsche Dijk 1 3741 LN Baarn The Netherlands
RMS	Netherlands
Date of last change	25.12.2018
ATC-Code	C10AA05 Atorvastatin

CMS Country	Domestic Product Name
Cyprus
France
Germany	Atorvastatin Aurobindo 40 mg Filmtabletten
Malta	Atorvastatin 40mg film coated tablets
Poland
Portugal
Romania	Atorvastatina Aurobindo 10 mg comprimate filmate
Spain
United Kingdom

Documents
PAR:	NL_H_2982_003_PAR.pdf (16.03.2015)
PARSummary:	NL_H_2982_003_PARSummary.pdf (16.03.2015)
FinalSPC:	NL_H_2982_003_FinalSPC.pdf (04.12.2018)
FinalPL:	NL_H_2982_003_FinalPL.pdf (04.12.2018)
FinalLabelling:	NL_H_2982_003_FinalLabelling.pdf (03.05.2018)
Finalised Product Information:	NL_H_2982_003_FinalPI.zip (04.07.2014)