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
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Roche Registration GmbH
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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.