Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
aripiprazole
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Aripiprazole Mylan Pharma. 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 Mylan Pharma.
For practical information about using Aripiprazole Mylan Pharma, patients should read the package leaflet or contact their doctor or pharmacist.
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Aripiprazole Mylan Pharma : EPAR - Summary for the public (PDF/113.09 KB)
First published: 20/07/2015
Last updated: 08/07/2016
EMA/276400/2015 -
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Aripiprazole Mylan Pharma : EPAR - Risk-management-plan summary (PDF/98.06 KB)
First published: 20/07/2015
Last updated: 12/01/2023
EMA/303592/2015
Authorisation details
Product details | |
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Name |
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
|
Agency product number |
EMEA/H/C/003803
|
Active substance |
aripiprazole
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International non-proprietary name (INN) or common name |
aripiprazole
|
Therapeutic area (MeSH) |
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Anatomical therapeutic chemical (ATC) code |
N05AX12
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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 |
Mylan Pharmaceuticals Limited
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Revision |
15
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Date of issue of marketing authorisation valid throughout the European Union |
30/06/2015
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Contact address |
Mylan Pharmaceuticals Limited |
Product information
15/12/2022 Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) - EMEA/H/C/003803 - WS2306
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 Mylan Pharma is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.
Aripiprazole Mylan Pharma 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 Mylan Pharma 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.