EMA Recommends a Change to the Terms of the Marketing Authorisation for Dabrafenib

EMA adopts an extension to the existing indication

On 23 July 2015, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product dabrafenib (Tafinlar).

The marketing authorisation holder for this medicinal product is Novartis Europharm Ltd.

The CHMP adopted an extension to the existing indication as follows: 

“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.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics, which will be published in the revised European public assessment report, and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.