EMEA-002342-PIP02-18-M03 - paediatric investigation plan

abemaciclib

Key facts

• Invented name:
  Verzenios
• Active substance:
  abemaciclib
• Therapeutic area:
  Oncology
• Decision number:
  P/0038/2024
• PIP number:
  EMEA-002342-PIP02-18-M03
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  • Treatment of glioma
  • Treatment of neuroblastoma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  07/02/2024
• Compliance check done:
  No

Decision

P/0038/2024 : EMA decision of 7 February 2024 on the acceptance of a modification of an agreed paediatric investigation plan for abemaciclib (Verzenios), (EMEA-002342-PIP02-18-M03)

Adopted Reference Number: EMA/45039/2024