EMEA-003288-PIP01-22 - paediatric investigation plan

bexicaserin

Key facts

• Active substance:
  bexicaserin
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0395/2024
• PIP number:
  EMEA-003288-PIP01-22
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of seizures and seizure disorders
• Route(s) of administration:
  • Oral use
  • Gastroenteral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  06/12/2024
• Compliance check done:
  No

Decision

P/0395/2024 : EMA decision of 6 December 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for bexicaserin (EMEA-003288-PIP01-22)

Adopted Reference Number: EMA/528864/2024