Tafinlar

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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 09/12/2021

Authorisation details

Product details
Name
Tafinlar
Agency product number
EMEA/H/C/002604
Active substance
dabrafenib mesilate
International non-proprietary name (INN) or common name
dabrafenib
Therapeutic area (MeSH)
Melanoma
Anatomical therapeutic chemical (ATC) code
L01EC02
Publication details
Marketing-authorisation holder
Novartis Europharm Limited
Revision
27
Date of issue of marketing authorisation valid throughout the European Union
26/08/2013
Contact address

Vista Building
Elm Park
Merrion Road
Dublin 4
Ireland

Product information

11/11/2021 Tafinlar - EMEA/H/C/002604 - WS2114

Product information documents contain:

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

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 (see sections 4.4 and 5.1).

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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