Braftovi
encorafenib
Table of contents
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.
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List item
Braftovi : EPAR - Medicine overview (PDF/120.84 KB)
First published: 12/10/2018
Last updated: 16/06/2020
EMA/244317/2020 -
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List item
Braftovi : EPAR - Risk-management-plan summary (PDF/160.87 KB)
First published: 12/10/2018
Last updated: 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) |
|
Anatomical therapeutic chemical (ATC) code |
L01EC03
|
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 | |
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Marketing-authorisation holder |
Pierre Fabre Medicament
|
Revision |
10
|
Date of issue of marketing authorisation valid throughout the European Union |
19/09/2018
|
Contact address |
Pierre Fabre Medicament |
Product information
25/07/2022 Braftovi - EMEA/H/C/004580 - II/0026
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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