KOSELUGO

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

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 more about Selumetinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
KOSELUGO Hard capsule	MPI, EU: SmPC	European Medicines Agency (EU)
KOSELUGO Capsule	MPI, US: SPL/PLR	FDA, National Drug Code (US)

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

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