MHRA-100084-PIP01-21-M02 (update)

Key Facts

Active Substance
Active Substance:
  • MIDOSTAURIN
Invented Name
  • Rydapt
  • Rydapt
PIP Number MHRA-100084-PIP01-21-M02 (update)
Pharmaceutical form(s)
  • Capsule, soft
  • Oral solution
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
  • Treatment of acute myeloid leukaemia
  • Treatment of malignant mastocytosis
  • Treatment of mast cell leukaemia.
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):MIDOSTAURIN.pdf
Published Date 24/06/2024