EMEA-001501-PIP07-20-M02 - paediatric investigation plan

dupilumab

Key facts

• Invented name:
  Dupixent
• Active substance:
  dupilumab
• Therapeutic area:
  Skin and subcutaneous tissue disorders
• Decision number:
  P/0353/2024
• PIP number:
  EMEA-001501-PIP07-20-M02
• Pharmaceutical form(s):
  Solution for injection in pre-filled syringe
• Condition(s) / indication(s):
  Treatment of chronic spontaneous urticaria
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  25/10/2024
• Compliance check done:
  Nein

Decision

P/0353/2024: EMA decision of 25 October 2024 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP07-20-M02)

Adopted Reference Number: EMA/443829/2024