Details
Product Name in the RMS: Aripiprazole "Orion"
MR Number: DK/H/2398/001
Date of outcome: 07.05.2015
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 |
Orion Corporation Orionintie 1 FI-02200 Finland |
RMS | Denmark |
Date of last change | 28.09.2020 |
ATC-Code |
N05AX12 Aripiprazole |
CMS Country | Domestic Product Name |
---|---|
Finland | |
Hungary | |
Poland | Aripiprazole Orion |
Sweden |
Documents | |
---|---|
PAR: | DK_H_2398_001_PAR.pdf (09.10.2015) |
PARSummary: | DK_H_2398_001_PARSummary.pdf (09.10.2015) |
FinalSPC: | DK_H_2398_001_FinalSPC.pdf (02.09.2020) |
FinalPL: | DK_H_2398_001_FinalPL.pdf (02.09.2020) |
FinalLabelling: | DK_H_2398_001_FinalLabelling.pdf (18.05.2018) |