Following a thorough and independent review, the TGA has decided that the following treatments meet the high safety, efficacy and quality standards required for use in Australia.
| Effective date | Sponsor | Name |
|---|---|---|
a. 24 February 2022 b. 12 December 2022 c. 12 December 2022 | AstraZeneca Pty Ltd | tixagevimab and cilgavimab (EVUSHELD) a. For pre-exposure prophylaxis in individuals 12 years and over (300mg dose regimen) b. For pre-exposure prophylaxis in individuals 12 years and over (increase to 600mg dose regimen) c. For the treatment of adults with COVID-19, who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19 d. Product voluntarily withdrawn by sponsor on 15 July 2024 |
| 18 January 2022 | Merck Sharp & Dohme (Australia) Pty Ltd | molnupiravir (LAGEVRIO) |
| Pfizer Australia Pty Ltd | nirmatrelvir + ritonavir (PAXLOVID) a. For the treatment of coronavirus disease 2019 (COVID-19) in adults 18 years of age and older, who do not require initiation of supplemental oxygen due to COVID-19 and are at increased risk of progression to hospitalisation or death. b. Transition to full registration approved |
| 6 December 2021 | Celltrion Healthcare Australia Pty Ltd | regdanvimab (REGKIRONA) |
| 1 December 2021 | Roche Products Pty Ltd | tocilizumab (ACTEMRA) |
| 15 October 2021 | Roche Products Pty Ltd | casirivimab + imdevimab (RONAPREVE) |
| 20 August 2021 | GlaxoSmithKline Australia Pty Ltd | Product voluntarily withdrawn by sponsor on 9 September 2024 |
a. 10 July 2020 b. 6 May 2022 | Gilead Sciences Pty Ltd | a. For treatment of COVID-19 in adults and adolescents (aged 12 years and weighing at least 40 kg) with pneumonia, requiring supplemental oxygen. b. For treatment of:
c. Transition to full registration under evaluation. |
Clinical guidelines may recommend the 'off-label' use of some medicines already included in the Australian Register of Therapeutic Goods (ARTG), such as dexamethasone, for the treatment of COVID-19. Off-label prescribing refers to the use of a registered medicine outside of the indications, dose, route of administration or patient group included in the TGA-approved Product Information (PI). Off-label use is not illegal, but is subject to the prescriber's clinical judgement in the setting of informed consent.
Labels for COVID-19 treatments
To enable timely distribution of COVID-19 treatments, international labels will be used during the initial supply in Australia.
Some information typically present on the Australian label may be absent and/or modified on the international label, as well as additional information present that is not relevant to the Australian context.