This brand name is authorized in Austria, Brazil, Canada, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States
The drug XOSPATA contains one active pharmaceutical ingredient (API):
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1
Gilteritinib
UNII 5RZZ0Z1GJT - GILTERITINIB FUMARATE
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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. |
Below package inserts are available for further reading:
| Title | Information Source | Document Type | |
|---|---|---|---|
| XOSPATA Tablet | FDA, National Drug Code (US) | MPI, US: SPL/PLR | |
| XOSPATA Film-coated tablet | European Medicines Agency (EU) | MPI, EU: SmPC |
This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:
| ATC code | Group title | Classification |
|---|---|---|
| L01EX13 | L Antineoplastic and immunomodulating agents → L01 Antineoplastic agents → L01E Protein kinase inhibitors → L01EX Other protein kinase inhibitors | |
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): 540320080003707 |
| Country: CA | Health Products and Food Branch | Identifier(s): 02495058 |
| Country: EE | Ravimiamet | Identifier(s): 1803833 |
| Country: FI | Lääkealan turvallisuus- ja kehittämiskeskus | Identifier(s): 082309 |
| Country: FR | Base de données publique des médicaments | Identifier(s): 66204797 |
| Country: GB | Medicines & Healthcare Products Regulatory Agency | Identifier(s): 378907 |
| Country: IL | מִשְׂרַד הַבְּרִיאוּת | Identifier(s): 8556 |
| Country: IT | Agenzia del Farmaco | Identifier(s): 048312019 |
| Country: JP | 医薬品医療機器総合機構 | Identifier(s): 4291053F1021 |
| Country: LT | Valstybinė vaistų kontrolės tarnyba | Identifier(s): 1088890 |
| Country: PL | Rejestru Produktów Leczniczych | Identifier(s): 100429728 |
| Country: RO | Agenția Națională a Medicamentului și a Dispozitivelor Medicale | Identifier(s): W67012001 |
| Country: TR | İlaç ve Tıbbi Cihaz Kurumu | Identifier(s): 8699043890468 |
| Country: US | FDA, National Drug Code | Identifier(s): 0469-1425 |
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