EMEA-001501-PIP08-20 - paediatric investigation plan

dupilumab

Key facts

• Invented name:
  Dupixent
• Active substance:
  dupilumab
• Therapeutic area:
  Oto-rhino-laryngology
• Decision number:
  P/0121/2021
• PIP number:
  EMEA-001501-PIP08-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic rhinosinusitis without nasal polyposis
• Route(s) of administration:
  Subcutaneous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  17/03/2021
• Compliance check done:
  No

Decision

P/0121/2021: EMA decision of 17 March 2021 on the refusal of a paediatric investigation plan and on the granting of a waiver for dupilumab (Dupixent), (EMEA-001501-PIP08-20)

Adopted Reference Number: EMA/97937/2021