EMEA-001501-PIP07-20-M01 - paediatric investigation plan

dupilumab

Key facts

• Invented name:
  Dupixent
• Active Substance:
  dupilumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0297/2023
• PIP number:
  EMEA-001501-PIP07-20-M01
• 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
• Contact for public enquiries:

  sanofi-aventis recherche & développement

  Tel. [phone]; E-mail: [e-mail]

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2023

Decision

P/0297/2023 : EMA decision of 11 August 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP07-20-M01)

Reference Number: EMA/336526/2023