EMEA-002763-PIP01-20-M01 - paediatric investigation plan

tovorafenib

Key facts

• Active substance:
  tovorafenib
• Therapeutic area:
  Oncology
• Decision number:
  P/0442/2023
• PIP number:
  EMEA-002763-PIP01-20-M01
• Pharmaceutical form(s):
  • Age appropriate oral formulation
  • Tablet
• Condition(s) / indication(s):
  Treatment of paediatric low grade glioma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/10/2023
• Compliance check done:
  No

Decision

P/0442/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for tovorafenib (EMEA- 002763-PIP01-20-M01)

Adopted Reference Number: EMA/401494/2023