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 02/03/2018

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
L01XX
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Sun Pharmaceutical Industries Europe B.V.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
13/08/2015
Contact address
Polarisavenue 87
2132JH Hoofddorp
The Netherlands

Product information

25/01/2018 Odomzo - EMEA/H/C/002839 - II/0016

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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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