Zelboraf

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vemurafenib

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

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.

This EPAR was last updated on 24/11/2021

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
L01EC01
Publication details
Marketing-authorisation holder
Roche Registration GmbH
Revision
22
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

04/11/2021 Zelboraf - EMEA/H/C/002409 - N/0060

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

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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