Olanzapine Cipla (previously Olanzapine Neopharma)

Withdrawn

This medicine's authorisation has been withdrawn

olanzapine

Overview

The marketing authorisation for Olanzapine Cipla has been withdrawn at the request of the marketing-authorisation holder.

Olanzapine Cipla : EPAR - Summary for the public

Product information

Olanzapine Cipla : EPAR - 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).

Olanzapine Cipla : EPAR - All Authorised presentations

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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/000793
• Generic:

  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.

• Marketing authorisation holder:
  Cipla (EU) Limited

  Cipla (EU) Limited ; Hillbrow House ; Hillbrow Road ; Esher ; Surrey ; KT10 9NW ; United Kingdom

• Marketing authorisation issued:
  14/11/2007
• Revision:
  12

Assessment history

Changes since initial authorisation of medicine

Olanzapine Cipla : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Olanzapine Cipla : EPAR - Scientific Discussion