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COVID-19 treatments: Provisional registrations

20 January 2022

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.

Treatments that have been provisionally approved by the TGA
Effective date Sponsor Name
18 January 2022 Merck Sharp & Dohme (Australia) Pty Ltd molnupiravir (LAGEVRIO)
18 January 2022 Pfizer Australia Pty Ltd nirmatrelvir + ritonavir (PAXLOVID)
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 Sotrovimab (XEVUDY)
10 July 2020 Gilead Sciences Pty Ltd remdesivir (VEKLURY)

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.

Consumer Medicine Information (CMI) for COVID-19 treatments

The CMI for each treatment is published and updated by the Australian sponsor. The CMI provides important information such as what you should know before you are given the treatment, including if you are taking other medicines, potential side effects, and a list of both active and inactive ingredients. To access the CMI you will need to click the "I accept" button from the links below.

CMI for Gilead Sciences Pty Ltd remdesivir (VEKLURY)

CMI for GlaxoSmithKline Australia Pty Ltd sotrovimab (XEVUDY)

CMI for Roche Products Pty Ltd casirivimab + imdevimab (RONAPREVE)

CMI for Roche Products Pty Ltd tocilizumab (ACTEMRA)

CMI for Celltrion Healthcare Australia Pty Ltd regdanvimab (REGKIRONA)

CMI for Pfizer Pty Ltd nirmatrelvir + ritonavir (PAXLOVID) (pdf,170kb)

CMI for Merck Sharp & Dohme (Australia) Pty Ltd molnupiravir (LAGEVRIO) (pdf,155kb)

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.

Labels for COVID-19 treatments