EMA/PE/0000233398 - paediatric investigation plan

fenfluramine hydrochloride

Key facts

• Invented name:
  Fintepla
• Active substance:
  fenfluramine hydrochloride
• Therapeutic area:
  Neurology
• Decision number:
  P/0390/2022
• PIP number:
  EMA/PE/0000233398
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of Dravet syndrome
• Route(s) of administration:
  • Oral use
  • Gastric use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  Ne

Decision

P/0390/2022: EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for fenfluramine hydrochloride (Fintepla) (EMA/PE/0000233398)

Adopted Reference Number: EMADOC-1700519818-2034841