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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Olanzapine Cipla has been withdrawn at the request of the marketing-authorisation holder.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

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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