Aripiprazole Sandoz
aripiprazole
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Aripiprazole Sandoz. 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 Aripiprazole Sandoz.
For practical information about using Aripiprazole Sandoz, patients should read the package leaflet or contact their doctor or pharmacist.
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Aripiprazole Sandoz : EPAR - Summary for the public (PDF/99.7 KB)
First published: 25/09/2015
Last updated: 25/09/2015 -
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Aripiprazole Sandoz : EPAR - Risk-management-plan summary (PDF/56.39 KB)
First published: 25/09/2015
Last updated: 25/09/2015
Authorisation details
Product details | |
---|---|
Name |
Aripiprazole Sandoz
|
Agency product number |
EMEA/H/C/004008
|
Active substance |
aripiprazole
|
International non-proprietary name (INN) or common name |
aripiprazole
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
N05AX12
|
Generic |
This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines. |
Publication details | |
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Marketing-authorisation holder |
Sandoz GmbH
|
Revision |
9
|
Date of issue of marketing authorisation valid throughout the European Union |
20/08/2015
|
Contact address |
Biochemiestr. 10
6250 Kundl Austria |
Product information
01/09/2022 Aripiprazole Sandoz - EMEA/H/C/004008 - IB/0023
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
Aripiprazole Sandoz is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Aripiprazole Sandoz 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.
Aripiprazole Sandoz 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.