Olazax Disperzi

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olanzapine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Olazax Disperzi. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Olazax Disperzi.

This EPAR was last updated on 09/10/2019

Authorisation details

Product details
Name
Olazax Disperzi
Agency product number
EMEA/H/C/001088
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
Glenmark Pharmaceuticals s.r.o. 
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
10/12/2009
Contact address
Glenmark Pharmaceuticals s.r.o.
Hvezdova 1716/2b
CZ-140 78 Praha 4
Czech Republic

Product information

12/09/2019 Olazax Disperzi - EMEA/H/C/001088 - WS/1650

Contents

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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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