Olanzapine Apotex

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olanzapine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European Public Assessment Report (EPAR) for Olanzapine Apotex. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Olanzapine Apotex.

This EPAR was last updated on 26/08/2019

Authorisation details

Product details
Name
Olanzapine Apotex
Agency product number
EMEA/H/C/001178
Active substance
olanzapine
International non-proprietary name (INN) or common name
olanzapine
Therapeutic area (MeSH)
  • Schizophrenia
  • Bipolar Disorder
Anatomical therapeutic chemical (ATC) code
N05AH03
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
Apotex Europe B.V. 
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
10/06/2010
Contact address

Apotex Europe B.V.
Archimedesweg 2
2333 CN, Leiden
The Netherlands
 

Product information

12/06/2019 Olanzapine Apotex - EMEA/H/C/001178 - IAIN/0035

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

Olanzapine is indicated for the treatment of schizophrenia.

Olanzapine is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial treatment response.

Olanzapine is indicated for the treatment of moderate to severe manic episode.

In patients whose manic episode has responded to olanzapine treatment, olanzapine is indicated for the prevention of recurrence in patients with bipolar disorder.

Assessment history

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