FINLEE

This brand name is authorized in Estonia, France, Croatia, Ireland, Italy, Lithuania, Romania

Active ingredients

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

1 Dabrafenib UNII QGP4HA4G1B - DABRAFENIB

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
FINLEE Dispersible tablet	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: EE	Ravimiamet	Identifier(s): 3056149, 3056150
Country: FR	Base de données publique des médicaments	Identifier(s): 61606482
Country: IT	Agenzia del Farmaco	Identifier(s): 050958014, 050958026
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1098140, 1098141
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W70094001, W70094002