MHRA-100160-PIP01-21-M01 (update)

Key Facts

Active Substance
Active Substance:
  • TOCILIZUMAB
Invented Name
  • RoActemra
  • RoActemra
PIP Number MHRA-100160-PIP01-21-M01 (update)
Pharmaceutical form(s)
  • Concentrate for solution for infusion
  • solution for injection
Therapeutic area
Therapeutic area:
  • Immunology -Rheumatology-Transplantation
Conditions / Indications
Conditions / Indications:
  • Cytokine release syndrome due to (CAR) T cell therapy or T-cell- bispecific antibody therapy
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
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 17/12/2021