EMEA-002559-PIP05-22 - paediatric investigation plan

Nipocalimab

Key facts

• Active Substance:
  Nipocalimab
• Therapeutic area:
  Dermatology
• Decision number:
  P/0344/2022
• PIP number:
  EMEA-002559-PIP05-22
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of bullous pemphigoid
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Contact for public enquiries:

  Janssen-Cilag International NV

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

• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Decision date:
  10/08/2022

Decision

P/0344/2022 : EMA decision of 10 August 2022 on the granting of a product specific waiver for nipocalimab (EMEA-002559-PIP05-22)

AdoptedReference Number: EMA/638322/2022