EMEA-001501-PIP04-19-M02 - paediatric investigation plan

dupilumab

Key facts

• Invented name:
  Dupixent
• Active substance:
  dupilumab
• Therapeutic area:
  Gastroentology-Hepatology
• Decision number:
  P/0541/2022
• PIP number:
  EMEA-001501-PIP04-19-M02
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of eosinophilic esophagitis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/12/2022
• Compliance check done:
  Igen
• Compliance procedure number:
  EMEA-C-001501-PIP04-19-M02
• Compliance opinion date:
  21/07/2023
• Compliance outcome:
  Positive

Decision

P/0541/2022: EMA decision of 30 December 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent), (EMEA-001501-PIP04-19-M02)

Adopted Reference Number: EMA/876005/2022