EMEA-001943-PIP01-16-M08 - paediatric investigation plan

ravulizumab

Key facts

• Invented name:
  Ultomiris
• Active substance:
  ravulizumab
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0379/2023
• PIP number:
  EMEA-001943-PIP01-16-M08
• Pharmaceutical form(s):
  • Concentrate for solution for infusion
  • Solution for injection
• Condition(s) / indication(s):
  Treatment of atypical haemolytic uremic syndrome
• 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
• Compliance check done:
  No

Decision

P/0379/2023 : EMA decision of 8 September 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris), (EMEA-001943-PIP01-16-M08)

Reference Number: EMA/351216/2023