Olanzapine Cipla (previously Olanzapine Neopharma)

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olanzapine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Olanzapine Cipla has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 24/07/2014

Authorisation details

Product details
Name
Olanzapine Cipla (previously Olanzapine Neopharma)
Agency product number
EMEA/H/C/000793
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
Cipla (EU) Limited
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
14/11/2007
Contact address
Cipla (EU) Limited
Hillbrow House
Hillbrow Road
Esher
Surrey
KT10 9NW
United Kingdom

Product information

28/11/2013 Olanzapine Cipla (previously Olanzapine Neopharma) - EMEA/H/C/000793 - IB/14

This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

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.

Assessment history

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