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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.

20 January 2021
The TGA has granted a provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to the COVID-19 Vaccine, NVX-CoV2373.
17 January 2021
In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine
4 December 2020
The medicine regulators from Australia, Canada, Singapore, Switzerland and the United Kingdom have discussed the regulatory evidence requirements for COVID-19 vaccine approvals and considerations for post-market pharmacovigilance.
2 December 2020
The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech.
18 November 2020
On 16 November 2020 the TGA granted a provisional determination to Janssen in relation to its COVID-19 vaccine, Ad26.COV2.S.
14 October 2020
The TGA has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA].
9 October 2020
The TGA has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant].
26 August 2020
Important information about the use of COVID-19 point-of-care tests.
7 May 2020
The TGA has issued an infringement notice for $2,520 to a woman in Western Australia for alleged breaches relating to COVID-19 test kits.
7 May 2020
The TGA has issued five infringement notices totalling $63,000 to a Queensland company for alleged breaches relating to COVID-19 test kits.

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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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