Olansek

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olanzapine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Olansek has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 12/06/2003

Authorisation details

Product details
Name
Olansek
Agency product number
EMEA/H/C/000114
Active substance
olanzapine
International non-proprietary name (INN) or common name
olanzapine
Therapeutic area (MeSH)
  • Schizophrenia
  • Bipolar Disorder
Anatomical therapeutic chemical (ATC) code
N05AH03
Publication details
Marketing-authorisation holder
Eli Lilly Co. Ltd.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
07/10/1996
Contact address
Eli Lilly and Company Limited
Erl Wood Manor
Sunningham Road
Windlesham, Surrey GU20 6PH
United Kingdom

Product information

17/03/2003 Olansek - EMEA/H/C/000114 -

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

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. Olanzapine has not been demonstrated to prevent recurrence of manic or depressive episodes (see Section 5.1).

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