🇪🇺 Aripiprazole tablet in European Union

EMA authorised Aripiprazole tablet on 22 May 2015

Marketing authorisations

Application: EMEA/H/C/003926
Marketing authorisation holder: Generics (UK) Limited
Local brand name: Aripiprazole Mylan
Indication: Treatment of schizophrenia and treatment and prevention of manic episodes in bipolar I disorder
Status: withdrawn

Application: EMEA/H/C/003899
Marketing authorisation holder: Zentiva, k.s.
Local brand name: Aripiprazole Zentiva
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.
Status: approved

Application: EMEA/H/C/003803
Marketing authorisation holder: Mylan Pharmaceuticals Limited
Local brand name: Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
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.
Status: approved

Application: EMEA/H/C/004008
Marketing authorisation holder: Sandoz GmbH
Local brand name: Aripiprazole Sandoz
Indication: Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Sandoz 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 Sandoz 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.
Status: approved

Application: EMEA/H/C/004021
Marketing authorisation holder: Accord Healthcare S.L.U.
Local brand name: Aripiprazole Accord
Indication: Aripiprazole Accord is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older. Aripiprazole Accord 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 Accord 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.
Status: approved

Application: EMEA/H/C/004236
Marketing authorisation holder: Mylan S.A.S.
Local brand name: Aripiprazole Mylan
Indication: Treatment of schizophrenia, treatment and prevention of bipolar disorder (manic episodes).
Status: withdrawn

Is Aripiprazole tablet approved in European Union?

Yes. EMA authorised it on 22 May 2015; EMA authorised it on 25 June 2015; EMA authorised it on 30 June 2015.

Who is the marketing authorisation holder for Aripiprazole tablet in European Union?

Generics (UK) Limited holds the EU marketing authorisation.