XOSPATA

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

Active ingredients

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

1	Gilteritinib UNII 5RZZ0Z1GJT - GILTERITINIB FUMARATE
	Gilteritinib fumarate is a FLT3 and AXL inhibitor. Gilteritinib inhibits FLT3 receptor signalling and proliferation in cells exogenously expressing FLT3 including FLT3-ITD, FLT3-D835Y, and FLT3-ITD-D835Y, and it induces apoptosis in leukemic cells expressing FLT3-ITD.
	Read more about Gilteritinib

Medication package inserts

Below package inserts are available for further reading:

Document	Type	Information Source
XOSPATA Tablet	MPI, US: SPL/PLR	FDA, National Drug Code (US)
XOSPATA Film-coated tablet	MPI, EU: SmPC	European Medicines Agency (EU)

Medicine classification

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

ATC Group		Classification
L01EX13		L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EX Other protein kinase inhibitors
Discover more medicines within L01EX13

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	540320080003707
CA	Health Products and Food Branch	02495058
EE	Ravimiamet	1803833
FI	Lääkealan turvallisuus- ja kehittämiskeskus	082309
FR	Base de données publique des médicaments	66204797
GB	Medicines & Healthcare Products Regulatory Agency	378907
IL	מִשְׂרַד הַבְּרִיאוּת	8556
IT	Agenzia del Farmaco	048312019
JP	医薬品医療機器総合機構	4291053F1021
LT	Valstybinė vaistų kontrolės tarnyba	1088890
PL	Rejestru Produktów Leczniczych	100429728
RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	W67012001
TR	İlaç ve Tıbbi Cihaz Kurumu	8699043890468
US	FDA, National Drug Code	0469-1425