KOSELUGO

This brand name is authorized in Brazil, Estonia, Finland, Ireland, Israel, 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: 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

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