EMEA-001943-PIP07-24 - paediatric investigation plan

ravulizumab

Key facts

• Invented name:
  Ultomiris
• Active substance:
  ravulizumab
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  P/0387/2024
• PIP number:
  EMEA-001943-PIP07-24
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of primary immunoglobulin A nephropathy
• Route(s) of administration:
  Intravenous use
• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  08/11/2024
• Compliance check done:
  No

Decision

P/0387/2024: EMA decision of 8 November 2024 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for ravulizumab (Ultomiris), (EMEA-001943-PIP07-24)

Adopted Reference Number: EMA/506319/2024