An overview of Zelboraf and why it is authorised in the EU
Zelboraf is a cancer medicine used to treat adults with melanoma (a type of skin cancer) that has spread to other parts of the body or cannot be surgically removed. Zelboraf is only for patients whose melanoma tumour cells have a specific mutation (genetic change) called ‘BRAF V600’.
Zelboraf contains the active substance vemurafenib.
Zelboraf : EPAR - Summary for the public (PDF/77.27 KB)
First published: 19/03/2012
Last updated: 12/04/2018
Zelboraf : EPAR - Risk-management-plan summary (PDF/128.16 KB)
First published: 23/08/2018
Last updated: 23/08/2018
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Roche Registration GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
14/08/2018 Zelboraf - EMEA/H/C/002409 - IB/0050
- 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
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Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.