Zelboraf

RSS

vemurafenib

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 23/08/2018

Authorisation details

Product details
Name
Zelboraf
Agency product number
EMEA/H/C/002409
Active substance
vemurafenib
International non-proprietary name (INN) or common name
vemurafenib
Therapeutic area (MeSH)
Melanoma
Anatomical therapeutic chemical (ATC) code
L01XE15
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
17/02/2012
Contact address
Emil-Barell-Strasse 1
79639 Grenzach-Wyhlen
Germany

Product information

14/08/2018 Zelboraf - EMEA/H/C/002409 - IB/0050

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

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.

Pharmacotherapeutic group

ANTINEOPLASTIC AGENTS

Therapeutic indication

Vemurafenib is indicated in monotherapy for the treatment of adult patients with BRAF-V600-mutation-positive unresectable or metastatic melanoma.

Assessment history

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