Odomzo
sonidegib
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Odomzo. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Odomzo.
For practical information about using Odomzo, patients should read the package leaflet or contact their doctor or pharmacist.
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Odomzo : EPAR - Summary for the public (PDF/75.99 KB)
First published: 02/09/2015
Last updated: 02/09/2015
EMA/452301/2015 -
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Odomzo : EPAR - Risk-management-plan summary (PDF/87.8 KB)
First published: 02/09/2015
Last updated: 02/09/2015
Authorisation details
Product details | |
---|---|
Name |
Odomzo
|
Agency product number |
EMEA/H/C/002839
|
Active substance |
sonidegib diphosphate
|
International non-proprietary name (INN) or common name |
sonidegib
|
Therapeutic area (MeSH) |
Carcinoma, Basal Cell
|
Anatomical therapeutic chemical (ATC) code |
L01XJ02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Sun Pharmaceutical Industries Europe B.V.
|
Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
14/08/2015
|
Contact address |
Polarisavenue 87 |
Product information
07/04/2021 Odomzo - EMEA/H/C/002839 - IA/0037
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.