Articles

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

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

TGA's participation in INTERPOL's Operation Pangea, which tackles the trade of illicit and counterfeit therapeutic goods worldwide, led to intercepting more than $2 million of illegally imported products.

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

Victoria-based Doughbot Enterprises fined $87,312 and undertakes to comply with advertising rules for nicotine vaping products.

TGA grants provisional determination for sabizabulin for the treatment of COVID-19

The TGA has issued a $2,664 infringement notice to a WA-based individual for allegedly importing liquid nicotine for use in nicotine vaping products.

The Federal Court of Australia has ordered Enviro Tech Holdings Pty Ltd to pay $80,000 for unlawful importation of surgical face masks.

The TGA has issued five infringement notices totalling $66,600 to 2San Pty Ltd for allegedly failing to provide information to the TGA to demonstrate the ongoing minimum level of sensitivity of two COVID-19 rapid antigen tests (RATs).

TGA commences evaluation of Pfizer's COVID-19 vaccine (COMIRNATY) for children aged 6 months to less than 5 years

The TGA has issued an infringement notice to a NSW-based individual for allegedly advertising nicotine vaping products for sale via their website.

The TGA has issued a direction notice to Phenix Health Pty Ltd (Phenix) to cease promoting the use and supply of nicotine vaping products to Australian consumers.

TGA accepts Enforceable Undertaking by Strapit Medical and Sports Supplies Pty Ltd in relation to breaches of the Therapeutic Goods Act.

TGA accepts Enforceable Undertaking by Strapit Medical and Sports Supplies Pty Ltd in relation to breaches of the Therapeutic Goods Act.

The TGA is aware of several incorrect recent media reports asserting that some COVID-19 rapid antigen tests have been removed from the market by the TGA for failing to detect the Omicron COVID-19 variant.

TGA has released over 95 batches of influenza vaccine, consisting of over 16.8 million doses, for supply in Australia for the 2022 influenza season.

The TGA has commenced Federal Court proceedings against Vapor Kings Pty Ltd and its sole director for alleged unlawful advertising of nicotine vaping products.

The TGA has provisionally approved the Biocelect Pty Ltd (on behalf of Novavax Inc.) COVID-19 vaccine, NUVAXOVID, for use in individuals aged 12 years and older.

The TGA has issued a direction notice to 13 Vape Pty Ltd and an executive officer to cease promoting the use and supply of nicotine vaping products to Australian consumers.

The TGA has issued 12 infringement notices totalling $31,698 to a NSW based individual for alleged unlawful advertising of disposable nicotine vaping products on several websites.

The TGA has provisionally approved a paediatric dose of the Moderna COVID-19 vaccine, SPIKEVAX, for use in individuals aged 6 months to less than 6 years (6 months to 5 years).

On 5 July 2022 the TGA granted two provisional determinations to Pfizer Australia Pty Ltd.