TAFINLAR

This brand name is authorized in United States. It is also authorized in Australia, Austria, Brazil, Canada, Croatia, Cyprus, Ecuador, Estonia, Finland, France, Hong Kong SAR China, Ireland, Israel, Italy, Japan, Lithuania, Netherlands, New Zealand, Poland, Romania, Singapore, South Africa, Spain, Turkey, UK.

Active ingredients

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

1	Dabrafenib UNII B6DC89I63E - DABRAFENIB MESYLATE
	Dabrafenib is an inhibitor of RAF kinases. Oncogenic mutations in BRAF lead to constitutive activation of the RAS/RAF/MEK/ERK pathway. BRAF mutations have been identified at a high frequency in specific cancers, including approximately 50% of melanoma. Dabrafenib demonstrated suppression of a downstream pharmacodynamic biomarker (phosphorylated ERK) and inhibited cell growth of BRAF V600 mutant melanoma cell lines, in vitro and in animal models.
	Read more about Dabrafenib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
TAFINLAR 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
L01EC02		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EC B-Raf serine-threonine kinase (BRAF) inhibitors
Discover more medicines within L01EC02

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	10003L, 11820D, 11823G, 2846T, 2954L, 2963Y
BR	Câmara de Regulação do Mercado de Medicamentos	526517050088717, 526517050088817, 526517050088917, 526517050089017
CA	Health Products and Food Branch	02409607, 02409615
EC	Agencia Nacional de Regulación, Control y Vigilancia Sanitaria	2722-MEE-0517, 2884-MEE-0617
EE	Ravimiamet	1624137, 1624148, 1624159, 1624160
ES	Centro de información online de medicamentos de la AEMPS	113865001, 113865003
FI	Lääkealan turvallisuus- ja kehittämiskeskus	066091, 079519, 409732, 507219
FR	Base de données publique des médicaments	60248840, 61477322
GB	Medicines & Healthcare Products Regulatory Agency	230706, 230709, 368982
HK	Department of Health Drug Office	63513, 63514
IE	Health Products Regulatory Authority	88430, 88432
IL	מִשְׂרַד הַבְּרִיאוּת	7415, 7417
IT	Agenzia del Farmaco	042923019, 042923021, 042923033, 042923045
JP	医薬品医療機器総合機構	4291046M1020, 4291046M2027
LT	Valstybinė vaistų kontrolės tarnyba	1071165, 1071166, 1071167, 1071168
NL	Z-Index G-Standaard, PRK	107123, 107131
NZ	Medicines and Medical Devices Safety Authority	16142, 16143
PL	Rejestru Produktów Leczniczych	100302123, 100302130
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W64724001, W64724002, W64725001, W64725002
SG	Health Sciences Authority	14830P, 14831P
TR	İlaç ve Tıbbi Cihaz Kurumu	8699504151008, 8699504151015, 8699504151022, 8699504151039
US	FDA, National Drug Code	0078-0681, 0078-0682, 0078-1154
ZA	Health Products Regulatory Authority	51/32.2/0817, 51/32.2/0818