Olanzapine Cipla (previously Olanzapine Neopharma)
olanzapine
Table of contents
Overview
The marketing authorisation for Olanzapine Cipla has been withdrawn at the request of the marketing-authorisation holder.
Authorisation details
| Product details | |
|---|---|
| Name |
Olanzapine Cipla (previously Olanzapine Neopharma)
|
| Agency product number |
EMEA/H/C/000793
|
| Active substance |
olanzapine
|
| International non-proprietary name (INN) or common name |
olanzapine
|
| Therapeutic area (MeSH) |
|
| Anatomical therapeutic chemical (ATC) code |
N05AH03
|
Generic |
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 |
Cipla (EU) Limited
|
| Revision |
12
|
| Date of issue of marketing authorisation valid throughout the European Union |
14/11/2007
|
| Contact address | |
Product information
28/11/2013 Olanzapine Cipla (previously Olanzapine Neopharma) - EMEA/H/C/000793 - IB/14
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.