EMEA-001943-PIP06-23 - paediatric investigation plan

ravulizumab

Key facts

• Invented name:
  Ultomiris
• Active substance:
  ravulizumab
• Therapeutic area:
  Uro-nephrology
• Decision number:
  P/0388/2023
• PIP number:
  EMEA-001943-PIP06-23
• Pharmaceutical form(s):
  Concentrate for solution for infusion
• Condition(s) / indication(s):
  Prevention of kidney injury in high-risk patients with chronic kidney disease undergoing cardiopulmonary bypass
• Route(s) of administration:
  Intravenous use
• Decision type:
  W: decision granting a waiver in all age groups for all conditions or indications
• Compliance check done:
  Nee

Decision

P/0388/2023 : EMA decision of 7 September 2023 on the granting of a product specific waiver for ravulizumab (Ultomiris), (EMEA-001943-PIP06-23)

Reference Number: EMA/389665/2023