MHRA-100213-PIP01-21-M03 (update)

Key Facts

Active Substance
Active Substance:
  • RAVULIZUMAB
Invented Name
Ultomiris
PIP Number MHRA-100213-PIP01-21-M03 (update)
Pharmaceutical form(s)
  • Solution for injection
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of paroxysmal nocturnal haemoglobinuria (PNH)
Route(s) of administration
  • Subcutaneous use
  • 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 Check Procedure Number
Compliance procedure number
MHRA-100213-PIP01-21-M03-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RAVULIZUMAB.pdf
Published Date 25/05/2023