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.
Erivedge : EPAR - Summary for the public (PDF/77.3 KB)
First published: 30/07/2013
Last updated: 17/11/2016
Erivedge : EPAR - Risk-management-plan summary (PDF/97.55 KB) (new)
First published: 13/10/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Carcinoma, Basal Cell
|Anatomical therapeutic chemical (ATC) code||
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
03/09/2020 Erivedge - EMEA/H/C/002602 - II/0046
- 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.
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