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🇪🇺EU · EMAAuthorisedATC: N05AX12

Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)(aripiprazole)

Schizophrenia;Bipolar Disorder

Marketing Authorisation Holder: Mylan Pharmaceuticals Limited

EMA Authorisation: 30/06/2015

INN: aripiprazole

Indication

Aripiprazole Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Mylan Pharma 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 Mylan Pharma 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.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.