Abilify Maintena
aripiprazole
Table of contents
Overview
Abilify Maintena is an antipsychotic medicine that contains the active substance aripiprazole. It is used for the maintenance treatment of schizophrenia in adults whose disease has already been stabilised with aripiprazole taken by mouth.
Schizophrenia is a mental illness with a number of symptoms, including disorganised thinking and speech, hallucinations (hearing or seeing things that are not there), suspiciousness and delusions (false beliefs).
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Abilify Maintena : EPAR - Summary for the public (PDF/129.85 KB)
First published: 28/11/2013
Last updated: 02/12/2020
EMA/556764/2020 -
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Abilify Maintena : EPAR - Risk-management-plan summary (PDF/221.13 KB)
First published: 14/09/2018
Last updated: 14/09/2018
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 |
20
|
Date of issue of marketing authorisation valid throughout the European Union |
14/11/2013
|
Contact address |
Herikerbergweg 292 |
Product information
20/07/2023 Abilify Maintena - EMEA/H/C/002755 - N/0046
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
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.
Pharmacotherapeutic group
Psycholeptics
Therapeutic indication
Maintenance treatment of schizophrenia in adult patients stabilised with oral aripiprazole.