Braftovi

RSS

encorafenib

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

Overview

Braftovi is a medicine for treating melanoma (a skin cancer) that has spread or cannot be removed by surgery.

Braftovi is used in combination with another medicine, binimetinib (Mektovi), and is only for patients whose cancer cells have a specific mutation (change) in their genes called 'BRAF V600'.

It contains the active substance encorafenib.

This EPAR was last updated on 12/10/2018

Authorisation details

Product details
Name
Braftovi
Agency product number
EMEA/H/C/004580
Active substance
Encorafenib
International non-proprietary name (INN) or common name
encorafenib
Therapeutic area (MeSH)
Melanoma
Anatomical therapeutic chemical (ATC) code
L01XE
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Pierre Fabre Medicament
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
19/09/2018
Contact address

45 Place Abel Gance
92100 Boulogne-Billancourt
France

Product information

25/07/2018 Braftovi - EMEA/H/C/004580 -

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

Encorafenib in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Assessment history

How useful was this page?

Add your rating
Average
6 ratings