We rigorously assess all COVID-19 treatments for safety, quality and effectiveness before they can be registered for use in Australia.
This page will be regularly updated to keep consumers, health professionals and sponsors informed of the latest regulatory developments.
Latest information on COVID-19 treatments
-
PageFind answers to the common questions you may have about how the TGA assesses and monitors a COVID-19 treatment for safety, quality and effectiveness.
-
PageInformation for sponsors of COVID-19 treatments on the provisional and full registration pathways.
-
PageCOVID-19 treatments that have received a provisional determination from the TGA.
-
PageCOVID-19 treatments that have provisional approval for use in Australia.
-
PageCOVID-19 treatments undergoing evaluation for provisional registration by the TGA.
More information
- TGA evaluating first monoclonal antibody treatment for COVID-19, SOTROVIMAB - GlaxoSmithKline Australia Pty Ltd
- COVID-19 treatment: Gilead Sciences Pty Ltd, remdesivir (VEKLURY)
- COVID-19 treatment: GlaxoSmithKline Australia Pty Ltd, sotrovimab (XEVUDY)
- COVID-19 treatment: Roche Products Pty Ltd, casirivimab + imdevimab (RONAPREVE)
- COVID-19 treatment: Roche Products Pty Ltd, tocilizumab (ACTEMRA)
- COVID-19 treatment: Celltrion Healthcare Australia Pty Ltd, regdanvimab (REGKIRONA)
- Extension to approved shelf-life for casirivimab + imdevimab (RONAPREVE)
Labelling exemptions
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Roche) (Casirivimab and Imdevimab) Labelling Exemption 2021
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Merck Sharp and Dohme) (Molnupiravir) Labelling Exemption 2022
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Pfizer) (Nirmatrelvir and Ritonavir) Labelling Exemption 2022
- Therapeutic Goods (Poisons Standard) (COVID-19 Medicine - AstraZeneca) (Tixagevimab and Cilgavimab) Labelling Exemption 2022
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2021
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2021
Provisional approval
- TGA provisionally approves Merck Sharp & Dohme (Australia) Pty Ltd's oral COVID-19 treatment, LAGEVRIO (molnupiravir)
- TGA provisionally approves Pfizer Australia Pty Ltd's COVID-19 treatment nirmatrelvir + ritonavir (PAXLOVID)
- TGA provisionally approves AstraZeneca's combination therapy (tixagevimab and cilgavimab, EVUSHELD) - for pre-exposure prevention (prophylaxis) of COVID-19
- Remdesivir granted provisional approval
Provisional determination
- TGA grants provisional determination to Glaxo SmithKline Australia Pty Ltd for COVID-19 monoclonal antibody treatment - SOTROVIMAB
- TGA approves provisional determination for Gilead Sciences Pty Ltd for COVID-19 treatment, VEKLURY (remdesivir), for proposed use in children and adults who are at risk of progressing to severe COVID-19
Alerts
-
AstraZeneca ChAdOx1-S COVID-19 vaccine: no evidence of increased risk of anaphylaxis
Safety alertsUpdate - Expert review finds no evidence of increased risk of anaphylaxis
News
-
TGA grants provisional approval to Pfizer’s COVID-19 bivalent (COMIRNATY Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccine
Media releasesThis is the first vaccine provisionally approved by the TGA that is designed to specifically target the Omicron variants BA.4/BA.5 and follows provisional approval of the Pfizer BA.1 Omicron/original bivalent vaccine. -
TGA grants provisional approval to Gilead Sciences Pty Ltd to extend the use of the COVID-19 treatment, VEKLURY (remdesivir)
Media releasesThe TGA has granted provisional approval to Gilead Sciences Pty Ltd to extend the use of the COVID-19 treatment, VEKLURY (remdesivir). -
TGA grants provisional determination for the Moderna bivalent COVID-19 vaccine "SPIKEVAX Bivalent Zero/Omicron"
Media releasesOn 27 April 2022 the TGA granted a provisional determination to Moderna Australia Pty Ltd in relation to its bivalent COVID-19 vaccine, elasomeran/elasomeran 0-omicron (SPIKEVAX Bivalent Zero/Omicron).