Olansek
Withdrawn
This medicine's authorisation has been withdrawn
olanzapine
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 7 October 1996, the European Commission granted a Community Marketing Authorisation valid throughout the European Union to Eli Lilly UK Ltd. for the medicinal product Olansek (olanzapine) indicated for the treatment of schizophrenia. The Marketing Authorisation for Olansek was renewed on 20 November 2001. Olansek has never been marketed in the European Union.
On 24 January 2003, the Marketing Authorisation Holder notified the European Commission of its decision to voluntarily withdraw the Community Marketing Authorisation for Olansek for commercial reasons. On 17 March 2003, the European Commission adopted the decision withdrawing the Community Marketing Authorisation for the medicinal product for human use Olansek.
Pursuant to this decision the European Public Assessment Report for Olansek has been removed from this website.
For information, it should be noted that there are still two Community Marketing Authorisations valid throughout the European Union for medicinal products containing olanzapine, i.e. Zyprexa and Zyprexa Velotab from Eli Lilly Nederland B.V.
Product information
17/03/2003
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).
Product details
- Name of medicine
- Olansek
- 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
PsycholepticsTherapeutic 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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