EMEA-001501-PIP11-21 - paediatric investigation plan

dupilumab

Key facts

• Invented name:
  Dupixent
• Active Substance:
  dupilumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0178/2022
• PIP number:
  EMEA-001501-PIP11-21
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of chronic puritus of unknown origin
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Sanofi-Aventis Groupe

  [e-mail]

  [phone]

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  13/05/2012

Decision

P/0178/2022 : EMA decision of 13 May 2022 on the granting of a product specific waiver for dupilumab (Dupixent), (EMEA-001501-PIP11-21)

AdoptedReference Number: EMA/205791/2022