Articles

This Order revokes Therapeutic Goods (Groups) Order No. 1 of 1992.

This Order may be cited as Therapeutic Goods (Groups) Order No. 1 of 1992.

This Order revokes Therapeutic Goods (Groups) Order No. 1 of 1991.

The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use as a booster in individuals aged 12 to 15 years old.

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Treatment—Merck Sharp and Dohme) (Molnupiravir) Labelling Exemption 2022.

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

The new Therapeutic Goods (Medicines Advisory Statements) Specification 2021 commences 1 January 2022

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

The TGA has granted a provisional determination to Moderna Australia Pty Ltd in relation to its COVID-19 vaccine, SPIKEVAX.

Introduction of requirements for sponsors of sartan medicines

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

On 1 October 2021, the TGA granted provisional determination to Pfizer Australia in relation to a new combination medicine containing PF-07321332 and ritonavir, for the treatment of adult patients with symptomatic, confirmed coronavirus infection.

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

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.

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.

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 approval to GlaxoSmithKline Australia Pty Ltd in relation to sotrovimab (XEVUDY).

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.

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.

This instrument is made under subregulations 4A.2(4) of the Therapeutic Goods (Medical Devices) Regulations 2002.