EMEA-001435-PIP02-16-M02 - paediatric investigation plan

anifrolumab

Key facts

• Invented name:
  Saphnelo
• Active substance:
  anifrolumab
• Therapeutic area:
  Immunology-Rheumatology-Transplantation
• Decision number:
  P/0149/2023
• PIP number:
  EMEA-001435-PIP02-16-M02
• Pharmaceutical form(s):
  • Solution for injection
  • Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of Systemic Lupus Erythematosus (SLE)
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  21/04/2023
• Compliance check done:
  Ei

Decision

P/0149/2023 : EMA decision of 21 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for anifrolumab (Saphnelo), (EMEA-001435-PIP02-16-M02)

Reference Number: EMA/170358/2023