MHRA-100079-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • GILTERITINIB FUMARATE
Invented Name
  • Xospata
  • Xospata
PIP Number MHRA-100079-PIP01-21-M02 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet Age appropriate oral dosage form
Therapeutic area
  • Haematology-Hemostaseology
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of acute myeloid leukemia
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):GILTERITINIB FUMARATE.pdf
Published Date 19/12/2023