Zyprexa Velotab

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 Velotab. 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 Velotab.

This EPAR was last updated on 24/04/2019

Authorisation details

Product details
Name
Zyprexa Velotab
Agency product number
EMEA/H/C/000287
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
28
Date of issue of marketing authorisation valid throughout the European Union
03/02/2000
Contact address
Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

06/02/2019 Zyprexa Velotab - EMEA/H/C/000287 - WS/1454

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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