BRAFTOVI

This brand name is authorized in Nigeria. It is also authorized in Australia, Austria, Croatia, Estonia, Finland, France, Ireland, Israel, Japan, Lithuania, Netherlands, Poland, Romania, Spain, UK, 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 more about Encorafenib

Packages

This drug has been approved in Nigeria as follows:

Identifier	Form	Presentation	Description	Approval
A4-100330	Capsule	Braftovi 50 mg Capsules CAP 50 mg 28's (in polyamide/aluminium/PVC/aluminium/ PET/paper perforated unit dose blisters)	Hard capsule (capsule). Orange opaque cap and flesh opaque body, printed with a stylised “A” on the cap and “LGX 50mg” on the body. The length of the capsule is approximately 22 mm	26/01/2023
A4-100331	Capsule	Braftovi 75 mg Capsules CAP 75 mg 42's (in polyamide/aluminium/PVC/aluminium/ PET/paper perforated unit dose blisters)	Hard capsule (capsule). Flesh coloured opaque cap and white opaque body, printed with a stylised “A” on the cap and “LGX 75mg” on the body. The length of the capsule is approximately 23 mm	26/01/2023

Medication package inserts

Below package inserts are available for further reading:

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

Medicine classification

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

ATC Group		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)
AU	Pharmaceutical Benefits Scheme	11937G, 11938H, 11949X, 11954E
EE	Ravimiamet	1780253, 1780275, 1804485, 1804496
ES	Centro de información online de medicamentos de la AEMPS	1181314001, 1181314002
FI	Lääkealan turvallisuus- ja kehittämiskeskus	408979, 421014
FR	Base de données publique des médicaments	60866559, 68671625
GB	Medicines & Healthcare Products Regulatory Agency	362829, 362845, 392273
IE	Health Products Regulatory Authority	88984, 88985
IL	מִשְׂרַד הַבְּרִיאוּת	8752
JP	医薬品医療機器総合機構	4291057M1029, 4291057M2025
LT	Valstybinė vaistų kontrolės tarnyba	1086237, 1086238, 1087723, 1087724
NG	Registered Drug Product Database	A4-100330, A4-100331
NL	Z-Index G-Standaard, PRK	167231, 167258
PL	Rejestru Produktów Leczniczych	100411220, 100411237
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W68698001, W68698002, W68699001, W68699002
US	FDA, National Drug Code	70255-025