MHRA-100213-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • RAVULIZUMAB
Invented Name
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
PIP Number MHRA-100213-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • Solution for injection
Therapeutic area
Therapeutic area:
  • Haematology-Hemostaseology
Conditions / Indications
Conditions / Indications:
  • Treatment of Paroxysmal Nocturnal Haemoglobinuria
Route(s) of administration
  • Intravenous use
  • Subcutaneous 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
02/03/2022
Compliance Check Procedure Number
Compliance procedure number
MHRA-100213-PIP01-21-M01 -C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RAVULIZUMAB.pdf
Published Date 17/05/2022