ACTEMRA (Roche Products Pty Ltd)
Product name
ACTEMRA
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
22 (255 working days)
Active ingredients
tocilizumab
Registration type
EOI
Indication
Disease and setting
Coronavirus disease 2019 (COVID-19) (IV formulation only)
ACTEMRA (concentrated injection) now also has provisional approval for the treatment of coronavirus disease 2019 (COVID-19) in hospitalised adults who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
Provisional approval has been made on the basis of short-term efficacy and safety data. Continued approval depends on the evidence of longer-term efficacy and safety from ongoing clinical trials and post-market assessment.
Registration process
Provisional registration
Involves early access to vital and life-saving medicines through time-limited registration