On 27 September 2021 the Therapeutic Goods Administration (TGA) granted provisional determination to Roche Products Pty Ltd in relation to the COVID-19 treatment tocilizumab (ACTEMRA).
This monoclonal antibody treatment is now eligible to be considered by the TGA for the intravenous treatment of confirmed COVID-19 in hospitalised adults aged 18 years and older who are receiving systemic corticosteroids and require supplemental oxygen or mechanical ventilation.
The granting of a provisional determination means that the TGA has made a decision that Roche Products Pty Ltd is now eligible to apply for provisional registration for ACTEMRA in the Australian Register of Therapeutic Goods (ARTG). Provisional determination is the first step in the process. It is anticipated that Roche Products Pty Ltd will submit an application for provisional registration shortly.