TGA evaluating first monoclonal antibody treatment for COVID-19, SOTROVIMAB - GlaxoSmithKline Australia Pty Ltd
The TGA granted a provisional determination to GlaxoSmithKline Australia Pty Ltd in relation to the monoclonal antibody treatment, SOTROVIMAB (GSK4182136) on 14 April 2021
- TGA grants provisional determination to Glaxo SmithKline Australia Pty Ltd for COVID-19 monoclonal antibody treatment - SOTROVIMABThe granting of a provisional determination means that the TGA has made a decision that GSK is now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods.
- TGA receives application for an increased dose of GlaxoSmithKline’s COVID-19 treatment sotrovimab (XEVUDY) for the BA.2 Omicron sublineageThe TGA has received an application from GlaxoSmithKline (GSK) Australia Pty Ltd for a higher (1000 mg) dose of its COVID‑19 treatment, sotrovimab (XEVUDY)
- TGA grants provisional determination to Celltrion Healthcare Australia Pty Ltd's antiviral COVID-19 treatment regdanvimabOn 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare Australia Pty Ltd in relation to regdanvimab.