EMEA-001943-PIP02-20-M02 - paediatric investigation plan

ravulizumab

Key facts

• Invented name:
  Ultomiris
• Active Substance:
  ravulizumab
• Therapeutic area:
  • Haematology-Hemostaseology
  • Uro-nephrology
• Decision number:
  P/0128/2023
• PIP number:
  EMEA-001943-PIP02-20-M02
• 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:
  14/04/2023

Decision

P/0128/2023 : EMA decision of 14 April 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris), (EMEA-001943-PIP02-20-M02)

Reference Number: EMA/108914/2023