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Coronavirus (COVID-19): Information on medicines and medical devices

The TGA is publishing the latest information about medicines and medical devices as it relates to COVID-19 on this page.

Please read the information below before contacting the TGA to see if your question is already answered.

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15 August 2022

The TGA has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID.

15 August 2022

COVID-19 treatments that have been provisionally approved for use in Australia

15 August 2022
The TGA has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 months to less than 6 years (6 months to 5 years).
11 August 2022
A list of tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG)
10 August 2022
The Federal Court of Australia has ordered Enviro Tech Holdings Pty Ltd to pay $80,000 for unlawful importation of surgical face masks.
10 August 2022
The TGA has issued five infringement notices totalling $66,600 to 2San Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests (RATs).
9 August 2022
The TGA is undertaking a post-market review of face masks included in the ARTG. This page lists all face masks that have been cancelled from the ARTG during the review.
8 August 2022

A list of self-tests that are approved in Australia

4 August 2022

The TGA is reviewing all laboratory antigen and Rapid Antigen Tests (RATs), including both point-of-care and self-tests, included in the ARTG.

3 August 2022

COVID-19 vaccines undergoing evaluation for provisional registration by the TGA

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Further information

Contact TGA Info

Tel: 1800 020 653
Email: info@tga.gov.au

Note: we are currently experiencing a high volume of calls and emails. Please bear with us as we try to respond to queries as quickly as possible.

Department of Health

Coronavirus (COVID-19) health alert — for information and advice not specific to therapeutic goods.

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