Olanzapine Apotex

Withdrawn

This medicine's authorisation has been withdrawn

olanzapine

Overview

On 12 August 2025, the European Commission withdrew the marketing authorisation for Olanzapine Apotex (olanzapine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Apotex Europe B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Olanzapine Apotex was granted marketing authorisation in the EU on 10 June 2010 for the treatment of schizophrenia and moderate to severe manic episode. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2014.

Olanzapine Apotex is a generic medicine of Zyprexa. There are other generic medicinal products of Zyprexa authorised and marketed in the EU. 

Olanzapine Apotex : EPAR - Summary for the public

Product information

Olanzapine Apotex : EPAR - Product Information

Olanzapine Apotex : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Olanzapine Apotex
• Active substance:
  olanzapine
• International non-proprietary name (INN) or common name:
  olanzapine
• Therapeutic area (MeSH):
  • Schizophrenia
  • Bipolar Disorder
• Anatomical therapeutic chemical (ATC) code:
  N05AH03

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.

Authorisation details

• EMA product number:
  EMEA/H/C/001178
• 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.

• Marketing authorisation holder:
  Apotex Europe BV

  Baarnsche Dijk 1; 3741 LN Baarn; The Netherlands

• Marketing authorisation issued:
  10/06/2010
• Withdrawal of marketing authorisation:
  12/08/2025
• Revision:
  13

Assessment history

Changes since initial authorisation of medicine

Olanzapine Apotex : EPAR - Procedural steps taken and scientific information after authorisation

Reference Number: EMA/175903/2020

Initial marketing authorisation documents

Olanzapine Apotex : EPAR - Public assessment report

CHMP positive summary of opinion for Olanzapine Apotex

Adopted Reference Number: EMA/148993/2010