Zyprexa

RSS

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 Zyprexa. 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 Zyprexa.

This EPAR was last updated on 28/02/2019

Authorisation details

Product details
Name
Zyprexa
Agency product number
EMEA/H/C/000115
Active substance
olanzapine
International non-proprietary name (INN) or common name
olanzapine
Therapeutic area (MeSH)
  • Schizophrenia
  • Bipolar Disorder
Anatomical therapeutic chemical (ATC) code
N05AH03
Publication details
Marketing-authorisation holder
Eli Lilly Nederland B.V.
Revision
39
Date of issue of marketing authorisation valid throughout the European Union
27/09/1996
Contact address
Eli Lilly Nederland BV
Papendorpseweg 83
3528 BJ Utrecht
Netherlands

Product information

18/02/2019 Zyprexa - EMEA/H/C/000115 - IG/0898

Contents

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Pharmacotherapeutic group

Psycholeptics

Therapeutic indication

Coated tablets

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.

Injection

Adults

Zyprexa powder for solution for injection is indicated for the rapid control of agitation and disturbed behaviours in patients with schizophrenia or manic episode, when oral therapy is not appropriate. Treatment with Zyprexa powder for solution for injection should be discontinued and the use of oral olanzapine should be initiated as soon as clinically appropriate.

Assessment history

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