PEMAZYRE

This brand name is authorized in Austria, Estonia, Spain, Finland, France, Croatia, Ireland, Israel, Japan, Lithuania, Poland, United Kingdom, United States

Active ingredients

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

1 Pemigatinib UNII Y6BX7BL23K - PEMIGATINIB

Pemigatinib is a kinase inhibitor of FGFR1, 2 and 3 which inhibits FGFR phosphorylation and signalling and decreases cell viability in cells expressing FGFR genetic alterations, including point mutations, amplifications, and fusions or rearrangements. FGFR2 fusions/rearrangements are strong oncogenic drivers and are the most common FGFR alteration occurring, almost exclusively, in 10-16% of intrahepatic cholangiocarcinoma (CCA). Read about Pemigatinib

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
PEMAZYRE Tablet	European Medicines Agency (EU)	MPI, EU: SmPC
PEMAZYRE Tablet	FDA, National Drug Code (US)	MPI, US: SPL/PLR

Medicine classification

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

ATC code	Group title	Classification
L01EN02	Pemigatinib	L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EN Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
Discover more medicines within L01EN02

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): 1845974, 1845985, 1845996, 1846009, 1846010, 1846021
Country: ES	Centro de información online de medicamentos de la AEMPS	Identifier(s): 1211535001, 1211535003, 1211535005
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 066041, 492808, 533157
Country: FR	Base de données publique des médicaments	Identifier(s): 61156252, 66412702, 67695203
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 399288, 399291, 399294
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 9027, 9028, 9029
Country: JP	医薬品医療機器総合機構	Identifier(s): 4291072F1024
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1092313, 1092314, 1092315, 1092316, 1092317, 1092318
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100450167, 100450174, 100450181
Country: US	FDA, National Drug Code	Identifier(s): 50881-026, 50881-027, 50881-028