Articles

The TGA has granted a provisional determination to Moderna Australia Pty Ltd’s bivalent COVID-19 vaccine candidate: elasomeran and davesomeran (SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4/BA.5)

The TGA has provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran), for children aged 6 months to less than 5 years

Direction and infringement notices given to MDNE Enterprises Pty Ltd for alleged unlawful advertising of nicotine vaping products

The TGA has issued a direction notice to MDNE Enterprises Pty Ltd to cease promoting the use and supply of nicotine vaping products to the Australian public.

Best Body Industries Pty Ltd fined for alleged unlawful advertising of sports supplements

Fines totalling $972,360 given to three medicinal cannabis companies for alleged unlawful advertising

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

The TGA has provisionally approved Pfizer's COVID-19 vaccine, COMIRNATY (tozinameran) for use as a booster dose in individuals 5 years to 11 years.

JSHealth Vitamins Pty Ltd fined for alleged unlawful advertising

Medicines safety update - Information for health professionals

The TGA has published an independent expert report examining the incidence of serious injury and death from intentional paracetamol overdose.

Medicines Safety Update - Information for health professionals

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

The TGA has approved the first two nasal combination self-tests (for use at home) that detect both COVID-19 and influenza viral infections in humans.

TGA approves asciminib and faricimab through the Access New Active Substance Work-Sharing Initiative

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Moderna) (Elasomeran and Imelasomeran) Labelling Exemption 2022.

The TGA has issued 7 infringement notices totalling $93,240 to Cyclotek Queensland Pty Ltd

WA-based company World Environmental Technologies Pty Ltd fined $13,320 for alleged unlawful importation of ivermectin, a prescription-only medicine.

TGA provisionally approves Moderna bivalent COVID-19 vaccine for use as a booster dose in adults

The TGA has provisionally approved Moderna's bivalent COVID-19 vaccine, elasomeran/imelasomeran (SPIKEVAX Bivalent Original/Omicron) for use as a booster dose in adults 18 years and over.

Section 7 declarations provide greater clarity for consumers, industry and regulators about whether a product is a therapeutic good.

The TGA has granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) for its COVID-19 vaccine, NUVAXOVID.

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

Update to the manufacturing principles for medicinal products

Doughbot Enterprises and its sole director have accepted an enforceable undertaking to not advertise nicotine vaping products or support their advertising.