EMEA-001990-PIP01-16-M05 - paediatric investigation plan

fenfluramine hydrochloride

Key facts

• Invented name:
  Fintepla
• Active Substance:
  fenfluramine hydrochloride
• Therapeutic area:
  Neurology
• Decision number:
  P/0390/2022
• PIP number:
  EMEA-001990-PIP01-16-M05
• 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:
  09/09/2022

Decision

P/0390/2022: EMA decision of 9 September 2022 on the acceptance of a modification of an agreed paediatric investigation plan for fenfluramine (hydrochloride) (Fintepla), (EMEA-001990-PIP01-16-M05)

Reference Number: EMA/677648/2022