Details

Product Name in the RMS: Aripiprazol AbZ 5 mg Tabletten

MR Number: DE/H/5039/001
Date of outcome: 12.03.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	aripiprazole 5 mg
Form	Tablet
MA Holder in the RMS	AbZ-Pharma GmbH - Geschäftsanschrift - Graf-Arco-Str. 3 D-89079 Ulm Germany
RMS	Germany
Date of last change	14.02.2019
ATC-Code	N05AX12 Aripiprazole

CMS Country	Domestic Product Name
Belgium	Aripiprazole Teva 5 mg tabletten/comprimés/Tabletten
Croatia	Aripiprazol Pliva 5 mg tablete
Denmark	Aripiprazole "Teva"
Ireland
Italy
Norway	Aripiprazole Teva
Spain
Sweden

Documents
PAR:	DE_H_5039_001_PAR.pdf (13.04.2015)
FinalSPC:	DE_H_5039_001_FinalSPC.pdf (06.06.2017)
FinalPL:	DE_H_5039_001_FinalPL.pdf (13.04.2015)
FinalLabelling:	DE_H_5039_001_FinalLabelling.pdf (13.04.2015)
Finalised Product Information:	DE_H_5039_001_FinalPI_1of3.pdf (26.10.2018)
Finalised Product Information:	DE_H_5039_001_FinalPI_2of3.pdf (26.10.2018)
Finalised Product Information:	DE_H_5039_001_FinalPI_3of3.pdf (26.10.2018)