EMEA-002064-PIP01-16-M03
Key facts
| Invented name |
Xospata
|
| Active substance |
Gilteritinib (as fumarate)
|
| Therapeutic area |
Haematology-Hemostaseology
|
| Decision number |
P/0110/2021
|
| PIP number |
EMEA-002064-PIP01-16-M03
|
| Pharmaceutical form(s) |
|
| Condition(s) / indication(s) |
Treatment of acute myeloid leukaemia
|
| Route(s) of administration |
Oral use
|
| Contact for public enquiries |
Astellas Pharma Europe B.V.
Tel. +31 7154 55878 |
| Decision type |
PM: decision on the application for modification of an agreed PIP
|