Olanzapine Cipla (previously Olanzapine Neopharma)

Withdrawn

This medicine's authorisation has been withdrawn

olanzapine

Overview

On 8 July 2014, the European Commission withdrew the marketing authorisation for Olanzapine Cipla (olanzapine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Cipla EU Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Olanzapine Cipla was granted marketing authorisation in the EU on 14 November 2007 for the treatment of adults with schizophrenia. It was also authorised to treat moderate to severe manic episodes in adults and in the prevention of recurrence of these episodes in adults with bipolar disorder. The marketing authorisation was initially valid for a 5-year period. It was then granted unlimited validity in 2012. 

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

The European Public Assessment Report (EPAR) for Olanzapine Cipla is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Olanzapine Cipla : EPAR - Summary for the public

Product information

Olanzapine Cipla : EPAR - Product Information

Olanzapine Cipla : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Olanzapine Cipla (previously Olanzapine Neopharma)
• 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

Adults

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/000793
• 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:
  Cipla (EU) Limited

  Cipla (EU) Limited ; Hillbrow House ; Hillbrow Road ; Esher ; Surrey ; KT10 9NW ; United Kingdom

• Marketing authorisation issued:
  14/11/2007
• Withdrawal of marketing authorisation:
  08/07/2013
• Revision:
  12

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Olanzapine Cipla : EPAR - Scientific Discussion