Abilify

RSS

aripiprazole

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 16/10/2018

Authorisation details

Product details
Name
Abilify
Agency product number
EMEA/H/C/000471
Active substance
aripiprazole
International non-proprietary name (INN) or common name
aripiprazole
Therapeutic area (MeSH)
  • Schizophrenia
  • Bipolar Disorder
Anatomical therapeutic chemical (ATC) code
N05AX12
Publication details
Marketing-authorisation holder
Otsuka Pharmaceutical Netherlands B.V.
Revision
42
Date of issue of marketing authorisation valid throughout the European Union
04/06/2004
Contact address

Herikerbergweg 292
1101 CT Amsterdam
Netherlands

Product information

23/08/2018 Abilify - EMEA/H/C/000471 - T/0131

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

PSYCHOLEPTICS

Therapeutic indication

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.

Assessment history

Changes since initial authorisation of medicine

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