MHRA-100118-PIP01-21-M04 (update)

Key Facts

Active Substance
Active Substance:
  • OCRELIZUMAB
Invented Name
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
  • Ocrevus
PIP Number MHRA-100118-PIP01-21-M04 (update)
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
Therapeutic area:
  • Neurology
Conditions / Indications
Conditions / Indications:
  • Treatment of Multiple Sclerosis
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 01707366000
  • Email uk.dra@roche.com
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-100118-pip01-21-M04-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):OCRELIZUMAB.pdf
Published Date 11/09/2025