Articles

On 27 September 2021 the TGA granted provisional determination to Roche Products Pty Ltd in relation to the COVID-19 treatment tocilizumab (ACTEMRA).

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

The TGA has issued two infringement notices totalling $26,640 to Tianda Pharmaceuticals Australia Pty Ltd for alleged unlawful advertising of a listed medicine in relation to COVID-19.

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.

Information about the Senate inquiry into the ‘Number of women in Australia who have had transvaginal mesh implants and related matters.’

On 28 March 2018, the Senate Community Affairs References Committee reported on its inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters - external site.

Medicines Safety Review

Lawyers for the TGA have written to United Australia Party leader, Mr Craig Kelly MP, alleging it has breached copyright and demanding that it stop distributing incomplete extracts of adverse event reports relating to COVID-19 vaccines which the TGA believes could be seriously misleading.

TGA has placed new restrictions on the prescribing of oral ivermectin

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

Medicines Safety Review

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)