Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)

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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 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.

This EPAR was last updated on 26/04/2019

Authorisation details

Product details
Name
Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen)
Agency product number
EMEA/H/C/003803
Active substance
aripiprazole
International non-proprietary name (INN) or common name
aripiprazole
Therapeutic area (MeSH)
  • Schizophrenia
  • Bipolar Disorder
Anatomical therapeutic chemical (ATC) code
N05AX12
GenericGeneric

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
Marketing-authorisation holder
Mylan S.A.S
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
30/06/2015
Contact address

117 Allee des Parcs
69800
Saint-Priest
France

Product information

13/03/2019 Aripiprazole Mylan Pharma (previously Aripiprazole Pharmathen) - EMEA/H/C/003803 - N/0010

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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