MHRA-100445-PIP01-22

Key Facts

Active Substance
Active Substance:
  • RAVULIZUMAB
Invented Name
  • Ultomiris
  • Ultomiris
  • Ultomiris
  • Ultomiris
PIP Number MHRA-100445-PIP01-22
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Neuromyelitis Optica Spectrum Disorder
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
Yes
Compliance Check Decision Date
Compliance Check Procedure Number
Compliance procedure number
MHRA-100445-PIP01-22-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):RAVULIZUMAB.pdf
Published Date 07/12/2022