EMEA-001501-PIP02-13-M08 - paediatric investigation plan

dupilumab

Key facts

• Invented name:
  Dupixent
• Active substance:
  dupilumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0396/2023
• PIP number:
  EMEA-001501-PIP02-13-M08
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of asthma
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  27/10/2023
• Compliance check done:
  No

Decision

P/0396/2023 : EMA decision of 27 October 2023 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP02-13-M08)

Adopted Reference Number: EMA/468097/2023