MHRA-101249-PIP01-23-M01 (update)

Key Facts

Active Substance
Active Substance:
  • Tovorafenib
Invented Name
Not yet available
PIP Number MHRA-101249-PIP01-23-M01 (update)
Pharmaceutical form(s)
  • Tablet
  • Age-appropriate oral liquid dosage form
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of paediatric low grade glioma
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
Yes
Compliance Check Decision Date
Compliance opinion date
23/06/2026
Compliance Check Procedure Number
Compliance procedure number
MHRA-101249-PIP01-23-M01-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Tovorafenib.pdf
Published Date 23/07/2026