MHRA-100573-PIP01-22

Key Facts

Active Substance
Active Substance:
  • Vorasidenib
Invented Name
Not yet available
PIP Number MHRA-100573-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of glioma
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
15/04/2024
Compliance Check Procedure Number
Compliance procedure number
MHRA-100573-PIP01-22-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Vorasidenib.pdf
Published Date 01/05/2026