EMEA-003090-PIP02-22 - paediatric investigation plan

deucrictibant

Key facts

• Active substance:
  deucrictibant
• Therapeutic area:
  Haematology-Hemostaseology
• Decision number:
  P/0411/2023
• PIP number:
  EMEA-003090-PIP02-22
• Pharmaceutical form(s):
  • Age appropriate oral solid dosage form
  • Capsule, soft
  • Prolonged-release tablet
• Condition(s) / indication(s):
  Treatment of hereditary angioedema
• 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:
  25/10/2023
• Compliance check done:
  No

Decision

P/0411/2023 : EMA decision of 25 October 2023 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for deucrictibant (EMEA-003090-PIP02-22)

Adopted Reference Number: EMA/469125/2023