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Aripiprazole Zentiva (aripiprazole)

Region

🇪🇺 EU

Active substance

aripiprazole

Company

Zentiva k.s.

Status

Authorised

Therapeutic area

Schizophrenia; Bipolar Disorder

CHMP opinion

Thu 23 Apr 2015

EU approval

Thu 25 Jun 2015

Designations

Generic

Application

EMEA/H/C/003899

ATC

N05AX12

Official record

www.ema.europa.eu

Indication

Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Zentiva 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. Aripiprazole Zentiva 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 Mylan Pharma (previously Aripiprazole Pharmathen) Authorised · Mylan Pharmaceuticals Limited
• 🇪🇺 Abilify Authorised · Otsuka Pharmaceutical Netherlands B.V.
• 🇪🇺 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• 🇪🇺 Asimtufii Application withdrawn · Otsuka Pharmaceutical Netherlands B.V.
• 🇪🇺 Abilify MyCite Application withdrawn · Otsuka Pharmaceutical Netherlands B.V.
• 🇪🇺 Aripiprazole Mylan Application withdrawn · Generics (UK) Limited
• 🇪🇺 Aripiprazole Mylan Application withdrawn · Mylan S.A.S.

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.