EMA/PE/0000228776 - paediatric investigation plan

abemaciclib

Key facts

• Invented name:
  Verzenios
• Active substance:
  abemaciclib
• Therapeutic area:
  Nervous system disorders
• Decision number:
  EMA/PE/0000228776
• PIP number:
  EMA/PE/0000228776
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral solid dosage form
• Condition(s) / indication(s):
  Treatment of glioma
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  28/01/2025
• Compliance check done:
  Níl

Decision

EMA/PE/0000228776 : EMA decision of 28 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for abemaciclib (Verzenios)

Adopted Reference Number: EMADOC-1700519818-1855225