Find the latest regulatory and safety information on COVID-19 treatments in Australia.
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
- 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)
- 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
- 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
- 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
Report a side effect
The TGA continues to monitor the safety of medicines after they are registered in Australia so that we can detect and respond to any safety concerns. If you think you may be experiencing a significant side effect (also known as an adverse event) to a COVID-19 treatment, you should seek advice from your doctor. Further information about adverse events can be found on the Reporting adverse events web page.
If you think you have experienced a side effect from a COVID-19 treatment you can report it via:
Telephone 1300 134 237 (8am-8pm seven days a week) – the NPS MedicineWise Adverse Medicine Events line
Online form TGA adverse event reporting
If you have an enquiry about the COVID-19 treatment regulatory process, use the following contact details:
Telephone 1800 020 653
If you have a general enquiry about COVID-19 or the vaccine roll-out, contact the National Coronavirus Helpline on:
Telephone 1800 020 080 (available 24 hours a day, seven days a week)
- TGA grants provisional approval to Pfizer’s COVID-19 bivalent (COMIRNATY Original/Omicron BA.4-5 COVID-19 vaccine) booster dose vaccineThis 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.