EMEA-000467-PIP01-08-M15 - paediatric investigation plan

perampanel

Key facts

• Invented name:
  Fycompa
• Active substance:
  perampanel
• Therapeutic area:
  Neurology
• Decision number:
  P/0521/2021
• PIP number:
  EMEA-000467-PIP01-08-M15
• Pharmaceutical form(s):
  • Tablet
  • Oral suspension
• Condition(s) / indication(s):
  Treatment of treatment-resistant epilepsies
• Route(s) of administration:
  Oral use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/12/2021
• Compliance check done:
  Nee

Decision

P/0521/2021 : EMA decision of of 3 December 2021 on the acceptance of a modification of an agreed paediatric investigation plan for perampanel (Fycompa), (EMEA-000467-PIP01-08-M15)

Adopted Reference Number: EMA/626828/2021