EMEA-002077-PIP01-16-M06 - paediatric investigation plan

ravulizumab

Key facts

• Invented name:
  Ultomiris
• Active Substance:
  ravulizumab
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0353/2023
• PIP number:
  EMEA-002077-PIP01-16-M06
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of paroxysmal nocturnal haemoglobinuria
• Route(s) of administration:
  • Intravenous use
  • Subcutaneous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  08/09/2023

Decision

P/0353/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris), (EMEA-002077-PIP01-16-M06)

Reference Number: EMA/380480/2023