TAFINLAR

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

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 about Dabrafenib

Medication package inserts

Below package inserts are available for further reading:

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