Abilify (aripiprazole)
- Region
- 🇪🇺 EU
- Active substance
- aripiprazole
- Company
- Otsuka Pharmaceutical Netherlands B.V.
- Status
- Authorised
- Therapeutic area
- Schizophrenia; Bipolar Disorder
- CHMP opinion
- Thu 26 Feb 2004
- EU approval
- Fri 04 Jun 2004
- Application
- EMEA/H/C/000471
- ATC
- N05AX12
- Official record
- www.ema.europa.eu
Indication
Abilify is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Abilify is indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder and for the prevention of a new manic episode in adults who experienced predominantly manic episodes and whose manic episodes responded to aripiprazole treatment. Abilify is indicated for the treatment up to 12 weeks of moderate to severe manic episodes in Bipolar I Disorder in adolescents aged 13 years and older.
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 Maintena 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- 🇪🇺 Asimtufii Application withdrawn · Otsuka Pharmaceutical Netherlands B.V.
- 🇪🇺 Abilify MyCite Application withdrawn · Otsuka Pharmaceutical Netherlands B.V.
- 🇪🇺 Aripiprazole Mylan Application withdrawn · Generics (UK) Limited
- 🇪🇺 Aripiprazole Mylan Application withdrawn · Mylan S.A.S.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.