Key Facts

PIPS Key Facts
Active Substance
Active Substance:
Invented Name
  • RoActemra
  • RoActemra
PIP Number MHRA-100120-PIP01-21
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Concentrate for solution for infusion
Therapeutic area
  • Infectious diseases
  • Other: Covid-19 pandemic
Conditions / Indications
Conditions / Indications:
  • Treatment of coronavirus disease 2019 (COVID-19)
Route(s) of administration
Route(s) of administration:
  • Intravenous use
PIP applicant
  • Roche Products Limited
  • Country United Kingdom
  • Tel 01707366000
  • Email
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
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

PIPS Decision Documents
Decision Document Decision Document on a Paediatric Investigation Plan (PIP):TOCILIZUMAB.pdf
Published Date 03/11/2021