Anpheros Search · Treatment

Aripiprazole

Also known as: Abilify · Abilify Maintena · Aripiprazole Zentiva · Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) · Aripiprazole Sandoz · Aripiprazole Accord

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In short

In the European Union, oral aripiprazole is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older, as well as for the maintenance treatment of schizophrenia in stabilised adult patients. In the United States, oral formulations of aripiprazole are indicated for the treatment of schizophrenia, the acute treatment of manic and mixed episodes associated with Bipolar I Disorder, the adjunctive treatment of Major Depressive Disorder, irritability associated with Autistic Disorder, and the treatment of Tourette's disorder. In the European Union, oral aripiprazole is also indicated for the treatment of moderate to severe manic episodes in Bipolar I Disorder in adults and in adolescents aged 13 years and older, and for the prevention of new manic episodes in adults whose episodes previously responded to the treatment.

From: Source: European Medicines Agency (EMA), Abilify — EPAR, 12/01/2026. © European Medicines Agency. · Source: European Medicines Agency (EMA), Abilify Maintena — EPAR, 28/10/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.

AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.

Codes

RxNorm
89013 aripiprazole
EMA
EMEA/H/C/000471, EMEA/H/C/002755, EMEA/H/C/003899, EMEA/H/C/003803, EMEA/H/C/004008, EMEA/H/C/004021

Official indications

Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.

EMA (EU) Abilify

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.

Source: European Medicines Agency (EMA), Abilify — EPAR, 12/01/2026. © European Medicines Agency.

Document date: 12/01/2026 · Official document →

EMA (EU) Abilify Maintena

Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.

Source: European Medicines Agency (EMA), Abilify Maintena — EPAR, 28/10/2025. © European Medicines Agency.

Document date: 28/10/2025 · Official document →

FDA (USA) aripiprazole

1 INDICATIONS AND USAGE Aripiprazole Oral Solution is indicated for the treatment of: Schizophrenia [see Clinical Studies (14.1) ] Acute Treatment of Manic and Mixed Episodes associated with Bipolar I Disorder [see Clinical Studies (14.2)] Adjunctive Treatment of Major Depressive Disorder [see Clinical Studies (14.3) ] Irritability Associated with Autistic Disorder [see Clinical Studies (14.4) ] Treatment of Tourette’s Disorder [see Clinical Studies ( 14.5 )] Aripiprazole is an atypical antipsychotic. The oral formulations are indicated for: Schizophrenia (14.1) Acute Treatment of Manic and Mixed Episodes associated with Bipolar I (14.2) Adjunctive Treatment of Major Depressive Disorder (14.3) Irritability Associated with Autistic Disorder (14.4) Treatment of Tourette's disorder (14.5)

Data provided by the U.S. Food and Drug Administration.

Document date: 20260903 · Official document →

Related terms in the cited sources

Has an official indication for

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External resources

Questions

What is Aripiprazole approved for in the European Union?

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. (Source: European Medicines Agency (EMA), Abilify — EPAR, 12/01/2026. © European Medicines Agency.)

Sources and attribution

  • Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
  • Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
  • Data provided by the U.S. Food and Drug Administration.
  • This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
  • Source: European Medicines Agency (EMA), Abilify — EPAR, 12/01/2026. © European Medicines Agency.
  • Source: European Medicines Agency (EMA), Abilify Maintena — EPAR, 28/10/2025. © European Medicines Agency.

Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →