EMEA-001501-PIP09-21 - paediatric investigation plan

dupilumab

Key facts

• Invented name:
  Dupixent
• Active substance:
  dupilumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0120/2022
• PIP number:
  EMEA-001501-PIP09-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic inducible cold urticaria
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  15/04/2022
• Compliance check done:
  Não

Decision

P/0120/2022 : EMA decision of 15 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for dupilumab (Dupixent), (EMEA-001501-PIP09-21)

Adopted Reference Number: EMA/149062/2022

Dupilumab (Dupixent) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision