Abilify Maintena (aripiprazole)
- Region
- 🇪🇺 EU
- Active substance
- aripiprazole
- Company
- Otsuka Pharmaceutical Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Schizophrenia
- CHMP opinion
- Wed 18 Sep 2013
- EU approval
- Thu 14 Nov 2013
- Application
- EMEA/H/C/002755
- ATC
- N05AX12
- Official record
- www.ema.europa.eu
Indication
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Aripiprazole Sandoz Authorised · Sandoz GmbH
- 🇪🇺 Aripiprazole Zentiva Authorised · Zentiva k.s.
- 🇪🇺 Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) Authorised · Mylan Pharmaceuticals Limited
- 🇪🇺 Abilify Authorised · Otsuka Pharmaceutical Netherlands B.V.
- 🇪🇺 Aripiprazole Accord Authorised · Accord Healthcare S.L.U.
- 🇪🇺 Asimtufii Application withdrawn · Otsuka Pharmaceutical Netherlands B.V.
- 🇪🇺 Abilify MyCite Application withdrawn · Otsuka Pharmaceutical Netherlands B.V.
- 🇪🇺 Aripiprazole Mylan Application withdrawn · Generics (UK) Limited
- 🇪🇺 Aripiprazole Mylan Application withdrawn · Mylan S.A.S.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.