This is a summary of the European public assessment report (EPAR) for Abilify Maintena. 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 Maintena.
For practical information about using Abilify Maintena, patients should read the package leaflet or contact their doctor or pharmacist.
Abilify Maintena : EPAR - Summary for the public (PDF/75.82 KB)
First published: 28/11/2013
Last updated: 09/03/2015
Abilify Maintena : EPAR - Risk-management-plan summary (PDF/221.13 KB)
First published: 14/09/2018
Last updated: 14/09/2018
|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||
29/04/2019 Abilify Maintena - EMEA/H/C/002755 - PSUSA/00000234/201807
- 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.
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.