Details

Product Name in the RMS: Atorvastatine Aurobindo 20 mg filmomhulde tabletten

MR Number: NL/H/2982/002
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 21,65 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	20.09.2021
ATC-Code	C10AA05 Atorvastatin

CMS Country	Domestic Product Name
Cyprus
France
Germany	Atorvastatin Aurobindo 20 mg Filmtabletten
Malta	Atorvastatin 20mg film coated tablets
Portugal
Romania	Atorvastatina Aurobindo 20 mg comprimate filmate
XI

Documents
PAR:	NL_H_2982_002_PAR.pdf (16.03.2015)
PARSummary:	NL_H_2982_002_PARSummary.pdf (16.03.2015)
FinalSPC:	NL_H_2982_002_FinalSPC.pdf (06.04.2020)
FinalPL:	NL_H_2982_002_FinalPL.pdf (06.04.2020)
FinalLabelling:	NL_H_2982_002_FinalLabelling.pdf (20.12.2018)
Finalised Product Information:	NL_H_2982_002_FinalPI.pdf (04.02.2021)