Erivedge

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vismodegib

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

Overview

This is a summary of the European public assessment report (EPAR) for Erivedge. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Erivedge.

For practical information about using Erivedge, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 28/03/2018

Authorisation details

Product details
Name
Erivedge
Agency product number
EMEA/H/C/002602
Active substance
vismodegib
International non-proprietary name (INN) or common name
vismodegib
Therapeutic area (MeSH)
Carcinoma, Basal Cell
Anatomical therapeutic chemical (ATC) code
L01XX43
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
Roche Registration GmbH
Revision
10
Date of issue of marketing authorisation valid throughout the European Union
11/07/2013
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

15/03/2018 Erivedge - EMEA/H/C/002602 - T/0037

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

Erivedge is indicated for the treatment of adult patients with:
- symptomatic metastatic basal cell carcinoma
- locally advanced basal cell carcinoma inappropriate for surgery or radiotherapy

Assessment history

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