KOSELUGO

This brand name is authorized in Brazil, Estonia, Finland, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, United States

Active ingredients

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

1 Selumetinib UNII 6UH91I579U - SELUMETINIB

Selumetinib is a selective inhibitor of mitogen activated protein kinase kinases 1 and 2 (MEK ½). Selumetinib blocks MEK activity and the RAF-MEK-ERK pathway. Therefore, MEK inhibition can block the proliferation and survival of tumour cells in which the RAF-MEK-ERK pathway is activated. Read about Selumetinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
KOSELUGO Capsule	FDA, National Drug Code (US)	MPI, US: SPL/PLR
KOSELUGO 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
L01EE04		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EE Mitogen-activated protein kinase (MEK) inhibitors
Discover more medicines within L01EE04

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 502321070034502, 502321070034602
Country: EE	Ravimiamet	Identifier(s): 1851476, 1851487
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 058548, 467554
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 8774, 8775
Country: IT	Agenzia del Farmaco	Identifier(s): 049540014, 049540026
Country: JP	医薬品医療機器総合機構	Identifier(s): 4299004M1025, 4299004M2021
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1092846, 1092847
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100455271, 100455296
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W67762001, W67763001
Country: US	FDA, National Drug Code	Identifier(s): 0310-0610, 0310-0625