This is a summary of the European public assessment report (EPAR) for Abilify. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Abilify.
For practical information about using Abilify, patients should read the package leaflet or contact their doctor or pharmacist.
Abilify : EPAR - Summary for the public (PDF/79.66 KB)
First published: 14/10/2009
Last updated: 27/01/2017
Abilify : EPAR - Risk-management-plan summary (PDF/217.86 KB)
First published: 19/07/2019
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Otsuka Pharmaceutical Netherlands B.V.
|Date of issue of marketing authorisation valid throughout the European Union||
28/03/2022 Abilify - EMEA/H/C/000471 - IB/0140
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 September 2016 (corrected)21/09/2016
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 201214/12/2012
Otsuka Pharmaceutical Europe Ltd withdraws its application for an extension of indication for Abilify (aripiprazole)19/11/2009