The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The Therapeutic Goods Administration (TGA) has received and assessed additional stability data submitted by Roche Products Pty Ltd for their COVID-19 treatment, casirivimab and imdevimab (RONAPREVE).
At the time of initial provisional registration for RONAPREVE, the shelf-life was 12 months when stored at 2°C to 8°C. The TGA has now approved an application from the sponsor for an extension of shelf-life to 18 months when stored at 2°C to 8°C.
The extended shelf-life applies to RONAPREVE available as 120 mg/mL solutions for infusion or injection in 300 mg single dose vials (AUST R 373839) and in 1332 mg multi-dose vials (AUST R 374310).
Due to the use of an international label, the expiry date printed on the label for RONAPREVE (24 months) does not reflect the TGA-approved shelf-life (18 months). Healthcare professionals should be aware of the TGA-approved shelf-life, and ensure that the products are used within the approved shelf-life (no later than 6 months prior to the printed expiry date on the international label).
An updated Dear Healthcare Professional Letter will be issued to inform end-users of the extended shelf-life (18 months).
The extended shelf-life applies to all batches of RONAPREVE supplied to Australia. Existing stock can be used no later than 6 months prior to the printed expiry date, provided that approved storage conditions between 2°C to 8°C have been maintained.