MHRA-100120-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • TOCILIZUMAB
Invented Name
  • RoActemra
  • RoActemra
PIP Number MHRA-100120-PIP01-21-M01 (update)
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
Decision Type
Decision Type
W: decision granting a waiver in all age groups for the listed condition(s).
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

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