Olanzapine Mylan

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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). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 16/04/2019

Authorisation details

Product details
Name
Olanzapine Mylan
Agency product number
EMEA/H/C/000961
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
Mylan S.A.S.
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
06/10/2008
Contact address
117 Allée des Parcs
69800 Saint Priest
France

Product information

07/03/2019 Olanzapine Mylan - EMEA/H/C/000961 - N/0047

Contents

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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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