Details

Product Name in the RMS: Aripiprazol Sandoz 15 mg

MR Number: NL/H/3231/002
Date of outcome: 22.07.2015

Type of application
Level 1: Level 2: Level 3: Level 4: Level 5:	Abridged Initial Application Generic Chemical Substance Prescription Only
Active Substances	aripiprazole 15 mg
Form	Orodispersible tablet
MA Holder in the RMS	Sandoz B.V. Veluwezoom 22 1327 AH Almere The Netherlands
RMS	Netherlands
Date of last change	17.11.2021
ATC-Code	N05AX12 Aripiprazole

CMS Country	Domestic Product Name
Austria	Aripiprazol Sandoz 15 mg – Schmelztabletten
Belgium	Aripiprazole Sandoz 15 mg, orodispergeerbare tabletten
France
Italy
Luxembourg
Poland	Aripiprazole Sandoz
Slovak Republic	Aripiprazol Sandoz 15 mg orodispergovateľné tablety
Spain

Documents
PAR:	NL_H_3231_002_PAR.pdf (28.09.2016)
PARSummary:	NL_H_3231_002_PARSummary.pdf (28.09.2016)
FinalSPC:	NL_H_3231_002_FinalSPC.pdf (08.11.2021)
FinalPL:	NL_H_3231_002_FinalPL.pdf (08.11.2021)
FinalLabelling:	NL_H_3231_002_FinalLabelling.pdf (08.11.2021)
Finalised Product Information:	NL_H_3231_002_FinalPI_1of3.pdf (27.10.2021)
Finalised Product Information:	NL_H_3231_002_FinalPI_2of3.pdf (27.10.2021)
Finalised Product Information:	NL_H_3231_002_FinalPI_3of3.pdf (27.10.2021)