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Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA has granted provisional approval to Moderna Australia Pty Ltd in relation to the COVID-19 vaccine, Spikevax (elasomeran), for individuals aged 12 years and over.

From 1 October 2021 you will no longer be able to legally buy nicotine vaping products, such as nicotine e-cigarettes, nicotine pods and liquid nicotine, from overseas websites without first getting a prescription.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Enforceable Undertaking given by Shen Neng Herbal Medicines Group Pty Ltd to the Department of Health

Joint statement from the TGA, Ahpra, Office of the Health Ombudsman and the Health Care Complaints Commission

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.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

Information about the TGA's safety monitoring of COVID-19 vaccines.

Conducting domestic inspections during the Coronavirus (COVID-19) pandemic

Ivermectin is a prescription medicine that is not approved in Australia (or in other OECD countries) to prevent or treat COVID-19 disease, and should not be imported for this indication.

On 20 August 2021 the TGA granted provisional determination to Roche Products Pty Ltd in relation to the combination therapy casirivimab + imdevimab (RONAPREVE)

On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare Australia Pty Ltd in relation to regdanvimab.

On 20 August 2021 the TGA granted provisional approval to GlaxoSmithKline Australia Pty Ltd in relation to sotrovimab (XEVUDY).

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

The TGA has approved AstraZeneca's submission to change the name of its COVID-19 Vaccine AstraZeneca to VAXZEVRIA.

Changes enhance transparency

The TGA is inviting consumers, health professionals, industry and other stakeholders to share their views in our annual stakeholder survey by 27 August 2021.

Information about the TGA's safety monitoring of COVID-19 vaccines.

The TGA has today approved for release doses of the Pfizer/BioNTech vaccine that arrived in Australia late last night from the Republic of Poland.

Users of nicotine vaping products are encouraged to make an appointment with their GP to discuss their smoking cessation options, ahead of changes from 1 October 2021.

Information about the TGA's safety monitoring of COVID-19 vaccines.