EMEA-003614-PIP01-24 - paediatric investigation plan

diazoxide choline

Key facts

• Active substance:
  diazoxide choline
• Therapeutic area:
  Congenital, familial and genetic disorders
• Decision number:
  P/0402/2024
• PIP number:
  EMEA-003614-PIP01-24
• Pharmaceutical form(s):
  • Prolonged-release tablet
  • Age-appropriate oral dosage form
• Condition(s) / indication(s):
  Treatment of Prader-Willi syndrome
• Route(s) of administration:
  Oral use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  18/12/2024
• Compliance check done:
  No

Decision

P/0402/2024: EMA decision of 18 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 diazoxide choline, (EMEA-003614-PIP01-24)

Adopted Reference Number: EMA/591389/2024