MHRA-101923-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Pimicotinib hydrochloride hydrate
Invented Name
Not yet available
PIP Number MHRA-101923-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsule, hard
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of tenosynovial giant cell tumours
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
06/08/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101923-PIP01-25-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Pimicotinib hydrochloride hydrate.pdf
Published Date 11/09/2025