Zelboraf
vemurafenib
Table of contents
Overview
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.
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Zelboraf : EPAR - Summary for the public (PDF/77.27 KB)
First published: 19/03/2012
Last updated: 12/04/2018
EMA/53181/2012 -
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Zelboraf : EPAR - Risk-management-plan summary (PDF/93.54 KB)
First published: 23/08/2018
Last updated: 30/01/2020
This EPAR was last updated on 30/01/2020
Authorisation details
Product details | |
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Name |
Zelboraf
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Agency product number |
EMEA/H/C/002409
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Active substance |
vemurafenib
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International non-proprietary name (INN) or common name |
vemurafenib
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Therapeutic area (MeSH) |
Melanoma
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Anatomical therapeutic chemical (ATC) code |
L01XE15
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Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
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Revision |
19
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Date of issue of marketing authorisation valid throughout the European Union |
17/02/2012
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Contact address |
Product information
31/10/2019 Zelboraf - EMEA/H/C/002409 - II/0054
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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Therapeutic indication
Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.