EMEA-001501-PIP01-13-M07 - paediatric investigation plan

dupilumab

Key facts

• Invented name:
  • Dupixent
  • Dupixent
• Active Substance:
  dupilumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0329/2021
• PIP number:
  EMEA-001501-PIP01-13-M07
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of atopic dermatitis
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Regeneron Pharmaceuticals Inc

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

• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  11/08/2021
• Compliance procedure number:
  EMEA-C-001501-PIP01-13-M07
• Compliance opinion date:
  25/02/2022
• Compliance outcome:
  Positive

Decision

P/0329/2021 : EMA decision of 11 August 2021 on the acceptance of a modification of an agreed paediatric investigation plan for dupilumab (Dupixent) (EMEA-001501-PIP01-13-M07)

AdoptedReference Number: EMA/434296/2021