EMA/PE/0000221604 - paediatric investigation plan

ravulizumab

Key facts

• Invented name:
  Ultomiris
• Active substance:
  ravulizumab
• Therapeutic area:
  Renal and urinary disorders
• Decision number:
  EMA/PE/0000221604
• PIP number:
  EMA/PE/0000221604
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of paroxysmal nocturnal haemoglobinuria
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  03/01/2025
• Compliance check done:
  No

Decision

EMA/PE/0000221604 : EMA decision of 3 January 2025 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris)

Adopted Reference Number: EMADOC-1700519818-1808060