MHRA-101233-PIP01-23-M01 (update)

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
  • inebilizumab
Invented Name
PIP Number MHRA-101233-PIP01-23-M01 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Solution for infusion Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of neuromyelitis optica spectrum disorders
Route(s) of administration
Route(s) of administration:
  • intravenous
PIP applicant
  • Amgen Limited
  • Country United Kingdom
  • Tel 07792443091
  • Email
Decision Type
Decision Type
PM: decision on the application for modification of an agreed paediatric investigation plan.
Compliance Check
Compliance Check
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):inebilizumab.pdf
Published Date 24/06/2024