Abilify Maintena

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 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.

This EPAR was last updated on 25/10/2018

Authorisation details

Product details
Name
Abilify Maintena
Agency product number
EMEA/H/C/002755
Active substance
aripiprazole
International non-proprietary name (INN) or common name
aripiprazole
Therapeutic area (MeSH)
Schizophrenia
Anatomical therapeutic chemical (ATC) code
N05AX12
Publication details
Marketing-authorisation holder
Otsuka Pharmaceutical Netherlands B.V.
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
14/11/2013
Contact address

Herikerbergweg 292
1101 CT Amsterdam
Netherlands

Product information

15/10/2018 Abilify Maintena - EMEA/H/C/002755 - T/0026

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

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

Assessment history

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