Zyprexa Velotab
olanzapine
Table of contents
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.
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) |
|
Anatomical therapeutic chemical (ATC) code |
N05AH03
|
Publication details | |
---|---|
Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
Revision |
29
|
Date of issue of marketing authorisation valid throughout the European Union |
03/02/2000
|
Contact address |
Product information
21/02/2020 Zyprexa Velotab - EMEA/H/C/000287 - PSUSA/00010540/201903
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.