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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.

23 September 2021
Updated guidance clarifying the interaction between TGA and AHPRA advertising guidelines.
21 September 2021

COVID-19 vaccine batch release information is now available.

9 September 2021

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

9 September 2021
On 9 August 2021 the TGA granted provisional approval to Moderna Australia Pty Ltd for its COVID-19 vaccine - SPIKEVAX (elasomeran) - making it the fourth COVID-19 vaccine to receive regulatory approval in Australia.
27 August 2021
The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.
27 August 2021
The Therapeutic Goods Administration (TGA) granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.
27 August 2021
The TGA has granted provisional approval to Pfizer Australia Pty Ltd for its COVID-19 vaccine, COMIRNATY, making it the first COVID-19 vaccine to receive regulatory approval in Australia.
27 August 2021
The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine
24 August 2021
Where suitable, TGA inspectors will undertake remote and/or hybrid Good Manufacturing Practice (GMP) domestic inspections during the COVID-19 pandemic.
23 July 2021
The Product Information (PI) used by healthcare professionals for COMIRNATY has been amended to include safety related information on myocarditis and pericarditis

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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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