Articles

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.

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

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.

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.

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

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.

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

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

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

The Federal Court of Australia has ordered Evolution Supplements Australia and its Director to pay $12 million