Braftovi

RSS

encorafenib

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

Overview

Braftovi is a medicine for treating certain cancers when their cells have a mutation (change) in their genes called 'BRAF V600'.

Braftovi is used in combination with another medicine, binimetinib  to treat melanoma (a skin cancer) that cannot be removed by surgery or has spread.

It is also used in combination with the medicine cetuximab to treat colorectal cancer (cancer of the large bowel or rectum) with the BRAF V600E version of the mutation, when it has spread elsewhere in the body and has previously been treated with other medicines.

It contains the active substance encorafenib.

This EPAR was last updated on 16/06/2020

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
L01XE46
Additional monitoringAdditional 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
4
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

02/06/2020 Braftovi - EMEA/H/C/004580 - WS/1695

Contents

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Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Encorafenib is indicated:

  • in combination with binimetinib is indicated for the treatment of adult patients with unresectable or metastatic melanoma with a BRAF V600 mutation
  • in combination with cetuximab, for the treatment of adult patients with metastatic colorectal cancer (CRC) with a BRAF V600E mutation, who have received prior systemic therapy

Assessment history

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