Odomzo

RSS

sonidegib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 26/04/2021

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
Date of issue of marketing authorisation valid throughout the European Union
14/08/2015
Contact address

Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Product information

07/04/2021 Odomzo - EMEA/H/C/002839 - IA/0037

Other EU languages available icon 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:

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.

Assessment history

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