EMEA-001501-PIP05-20 - paediatric investigation plan

dupilumab

Key facts

• Invented name:
  Dupixent
• Active Substance:
  dupilumab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0304/2020
• PIP number:
  EMEA-001501-PIP05-20
• Pharmaceutical form(s):
  Solution for injection
• Condition(s) / indication(s):
  Treatment of bullous pemphigoid
• Route(s) of administration:
  Subcutaneous use
• Contact for public enquiries:

  Regeneron Ireland DAC

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  12/08/2020

Decision

P/0304/2020 : EMA decision of 12 August 2020 on the granting of a product specific waiver for dupilumab, Dupixent (EMEA-001501-PIP05-20)

AdoptedReference Number: EMA/414770/2020