EMEA-002572-PIP02-19-M05 - paediatric investigation plan

soticlestat

Key facts

• Active substance:
  soticlestat
• Therapeutic area:
  Nervous system disorders
• Decision number:
  P/0194/2024
• PIP number:
  EMEA-002572-PIP02-19-M05
• Pharmaceutical form(s):
  • Film-coated tablet
  • Age appropriate oral formulation
• Condition(s) / indication(s):
  • Treatment of Dravet syndrome
  • Treatment of Lennox-Gastaut syndrome
• Route(s) of administration:
  • Oral use
  • Gastric use
  • Intestinal use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/06/2024
• Compliance check done:
  No

Decision

P/0194/2024: EMA decision of 14 June 2024 on the acceptance of a modification of an agreed paediatric investigation plan for soticlestat, (EMEA- 002572-PIP02-19-M05)

Adopted Reference Number: EMA/248085/2024