MHRA-101204-PIP01-23

Key Facts

Active Substance
Active Substance:
  • Ravulizumab (ALXN1210)
Invented Name
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
PIP Number MHRA-101204-PIP01-23
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Uro-Nephrology
Conditions / Indications
Conditions / Indications:
  • Prevention of kidney injury in high-risk patients with chronic kidney disease undergoing cardiopulmonary bypass
Route(s) of administration
Route(s) of administration:
  • intravenous
PIP applicant
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Ravulizumab (ALXN1210).pdf
Published Date 03/10/2024