Olanzapine Cipla (previously Olanzapine Neopharma)
Withdrawn
This medicine's authorisation has been withdrawn
olanzapine
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
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Report (EPAR) for Olanzapine Cipla is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IB/14
28/11/2013
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
- 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
PsycholepticsTherapeutic 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.
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