Articles

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

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.

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.

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

TGA has placed new restrictions on the prescribing of oral ivermectin

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.

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.

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.

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.

On 9 August 2021 the TGA granted provisional determination to Merck Sharp & Dohme (Australia) Pty Ltd (MSD) in relation to Molnupiravir.

On 9 August 2021 the TGA granted provisional approval to Moderna Australia Pty Ltd in relation to the COVID-19 vaccine, Spikevax (elasomeran), for individuals aged 18 years and over.

The Minamata Convention facilitates a global approach to address concerns relating to mercury, which is persistent, toxic and highly mobile in the environment once released, and recognised as a substance producing significant neurological and other effects in humans.

The TGA has issued twenty infringement notices totalling $266,400 to a Canberra-based dental practice.