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
|