EMEA-001943-PIP04-20-M01 - paediatric investigation plan

ravulizumab

Key facts

• Invented name:
  Ultomiris
• Active Substance:
  ravulizumab
• Therapeutic area:
  Neurology
• Decision number:
  P/0482/2023
• PIP number:
  EMEA-001943-PIP04-20-M01
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Treatment of neuromyelitis optica spectrum disorders
• Route(s) of administration:
  Intravenous use
• Decision type:
  PM: decision on the application for modification of an agreed PIP
• Decision date:
  30/11/2023

Decision

P/0482/2023: EMA decision of 30 November 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ravulizumab (Ultomiris), (EMEA-001943-PIP04-20-M01)

AdoptedReference Number: EMA/494329/2023