Erivedge
vismodegib
Table of contents
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.
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List item
Erivedge : EPAR - Summary for the public (PDF/77.3 KB)
First published: 30/07/2013
Last updated: 17/11/2016 -
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List item
Erivedge : EPAR - Risk-management-plan summary (PDF/97.55 KB)
First published: 13/10/2020
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
|
Publication details | |
---|---|
Marketing-authorisation holder |
Roche Registration GmbH
|
Revision |
15
|
Date of issue of marketing authorisation valid throughout the European Union |
12/07/2013
|
Contact address |
Emil-Barell-Strasse 1 |
Product information
15/03/2023 Erivedge - EMEA/H/C/002602 - N/0053
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
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