PEMAZYRE

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

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 more about Pemigatinib

Medication package inserts

Below package inserts are available for further reading:

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