FINLEE

This brand name is authorized in Croatia, Estonia, France, 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 more about Dabrafenib

Medication package inserts

Below package inserts are available for further reading:

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