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 | 22.10.2020 |
ATC-Code |
N05AX12 Aripiprazole |
CMS Country | Domestic Product Name |
---|---|
Austria | Aripiprazol Sandoz 15 mg – Schmelztabletten |
Belgium | Aripiprazole Sandoz 15 mg, orodispergeerbare tabletten |
France | |
Germany | Aripiprazol HEXAL 15 mg Schmelztabletten |
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 (22.10.2020) |
FinalPL: | NL_H_3231_002_FinalPL.pdf (22.10.2020) |
FinalLabelling: | NL_H_3231_002_FinalLabelling.pdf (22.10.2020) |
Finalised Product Information: | NL_H_3231_002_FinalPI.pdf (23.07.2015) |