BRAFTOVI

This brand name is authorized in Austria, Australia, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, United Kingdom, United States

Active ingredients

The drug BRAFTOVI contains one active pharmaceutical ingredient (API):

1 Encorafenib UNII 8L7891MRB6 - ENCORAFENIB

Encorafenib is a potent and highly selective ATP-competitive small molecule RAF kinase inhibitor. Encorafenib suppresses the RAF/MEK/ERK pathway in tumour cells expressing several mutated forms of BRAF kinase (V600E, D and K). Specifically, encorafenib inhibits in vitro and in vivo BRAFV600E,DandK mutant melanoma cell growth. Read about Encorafenib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
BRAFTOVI Hard capsule	European Medicines Agency (EU)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
L01EC03		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EC B-Raf serine-threonine kinase (BRAF) inhibitors
Discover more medicines within L01EC03

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 11937G, 11938H, 11949X, 11954E
Country: EE	Ravimiamet	Identifier(s): 1780253, 1780275, 1804485, 1804496
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1181314001, 1181314002
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 408979, 421014
Country: FR	Base de données publique des médicaments	Identifier(s): 60866559, 68671625
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 362829, 362845, 392273
Country: IE	Health Products Regulatory Authority	Identifier(s): 88984, 88985
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8752
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291057M1029, 4291057M2025
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1086237, 1086238, 1087723, 1087724
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 167231, 167258
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100411220, 100411237
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W68698001, W68698002, W68699001, W68699002
Country: US	FDA, National Drug Code	Identifier(s): 70255-025