EMA/PE/0000229605 - paediatric investigation plan

ravulizumab

Key facts

• Invented name:
  Ultomiris
• Active substance:
  ravulizumab
• Therapeutic area:
  Blood and lymphatic system disorders
• Decision number:
  P/0128/2023
• PIP number:
  EMA/PE/0000229605
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment in haematopoietic stem cell transplantation
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  14/04/2025
• Compliance check done:
  No

Decision

P/0128/2023 : EMA decision of 14 April 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris) (EMA/PE/0000229605)

Adopted Reference Number: EMADOC-1700519818-2034248