Source: European Medicines Agency (EU) Revision Year: 2023 Publisher: Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
Xospata 40 mg film-coated tablets.
| Pharmaceutical Form |
|---|
|
Film-coated tablet (tablet). Round, light yellow film-coated tablet, debossed with the company logo and ‘235’ on the same side. |
Each film-coated tablet contains 40 mg gilteritinib (as fumarate).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Gilteritinib |
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. |
| List of Excipients |
|---|
|
Tablet core: Mannitol (E421) Film-coating: Hypromellose |
OPA/aluminium/PVC/aluminium blisters containing 21 film-coated tablets.
Each pack contains 84 film-coated tablets.
Astellas Pharma Europe B.V., Sylviusweg 62, 2333 BE Leiden, The Netherlands
EU/1/19/1399/001
Date of first authorisation: 24 October 2019
| Drug | Countries | |
|---|---|---|
| XOSPATA | Austria, Brazil, Canada, Estonia, Finland, France, Croatia, Ireland, Israel, Italy, Japan, Lithuania, Poland, Romania, Turkey, United Kingdom, United States |
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