Aripiprazole Zentiva

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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 Zentiva. 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 Zentiva.

For practical information about using Aripiprazole Zentiva, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 07/03/2018

Authorisation details

Product details
Name
Aripiprazole Zentiva
Agency product number
EMEA/H/C/003899
Active substance
aripiprazole
International non-proprietary name (INN) or common name
aripiprazole
Therapeutic area (MeSH)
  • Schizophrenia
  • Bipolar Disorder
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 medicines.

Publication details
Marketing-authorisation holder
Zentiva, k.s.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
25/06/2015
Contact address
U kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic

Product information

06/02/2018 Aripiprazole Zentiva - EMEA/H/C/003899 - IB/0008

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

Aripiprazole Zentiva is indicated for the treatment of schizophrenia in adults and in adolescents aged 15 years and older.

Aripiprazole Zentiva 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 Zentiva 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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