Tafinlar

RSS

dabrafenib

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

Overview

Tafinlar is a cancer medicine used to treat adults whose cancer cells have a specific genetic mutation (change) called ‘BRAF V600’. It is used for the treatment of:

  • melanoma (a skin cancer) that has spread or cannot be removed surgically. Tafinlar is used on its own or in combination with another cancer medicine, trametinib;
  • advanced (stage III) melanoma after surgery for it. Tafinlar is used in combination with trametinib;
  • advanced non-small cell lung cancer. It is used in combination with trametinib.

Tafinlar contains the active substance dabrafenib.

This EPAR was last updated on 11/09/2018

Authorisation details

Product details
Name
Tafinlar
Agency product number
EMEA/H/C/002604
Active substance
dabrafenib mesylate
International non-proprietary name (INN) or common name
dabrafenib
Therapeutic area (MeSH)
Melanoma
Anatomical therapeutic chemical (ATC) code
L01XE23
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
18
Date of issue of marketing authorisation valid throughout the European Union
25/08/2013
Contact address
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

26/08/2018 Tafinlar - EMEA/H/C/002604 - WS/1274

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

Melanoma
Dabrafenib as monotherapy or in combination with trametinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Adjuvant treatment of melanoma
Dabrafenib in combination with trametinib is indicated for the adjuvant treatment of adult patients with Stage III melanoma with a BRAF V600 mutation, following complete resection.

Non small cell lung cancer (NSCLC)
Dabrafenib in combination with trametinib is indicated for the treatment of adult patients with advanced non small cell lung cancer with a BRAF V600 mutation.

Assessment history

Changes since initial authorisation of medicine

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