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

Key Facts

PIPS Key Facts
Active Substance
Active Substance:
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
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):TOCILIZUMAB.pdf
Published Date 17/12/2021