EMEA-000309-PIP04-17-M03

Table of contents

Key facts

Invented name
RoActemra
Active substance
tocilizumab
Therapeutic area
Immunology-Rheumatology-Transplantation
Decision number
P/0303/2021
PIP number
EMEA-000309-PIP04-17-M03
Pharmaceutical form(s)
  • Solution for injection
  • Concentrate for solution for infusion
Condition(s) / indication(s)
Treatment of cytokine release syndrome associated with chimeric antigen receptor (CAR) T cell therapy or T-cell-engaging bispecific antibody therapy
Route(s) of administration
  • Subcutaneous use
  • Intravenous use
Contact for public enquiries
Roche Registration GmbH

Tel. +41 616879411
E-mail: info.paediatrics@roche.com

Decision type
PM: decision on the application for modification of an agreed PIP

Decision

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