MHRA-100213-PIP01-21-M05 (update)

Key Facts

Active Substance
Active Substance:
  • RAVULIZUMAB
Invented Name
Ultomiris
PIP Number MHRA-100213-PIP01-21-M05 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of paroxysmal nocturnal haemoglobinuria
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance opinion date
08/07/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-100213-PIP01-21-M05-C

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RAVULIZUMAB.pdf
Published Date 14/07/2025