Articles

2022 seasonal Influenza vaccines

The TGA has issued an infringement notice for $13,320 to Vaxine Pty Ltd of Adelaide for advertising an unapproved COVID-19 vaccine in alleged breach of the Therapeutic Goods Act 1989.

TGA, part of the Department of Health, has granted a second provisional determination to Biocelect Pty Ltd (on behalf of Novavax Inc.) in relation to its COVID-19 vaccine, Nuvaxovid.

The TGA has issued an infringement notice of $13,320 to Getafix Café Pty Ltd (the company) for an alleged breach of the Therapeutic Goods Act 1989 in relation to the advertising of a COVID-19 rapid antigen test on its website.

Gold Coast company FuturePro Pty Ltd, trading as Inet Herbal, has pleaded guilty to seven breaches of the Therapeutic Goods Act 1989.

The TGA has issued two infringement notices totalling $26,640 to DPD Stores Pty Ltd, trading as Lanyon Newsagency in the ACT, in relation to alleged unlawful supply of nicotine vaping products.

The TGA has issued an infringement notice for $7,992 to a Melbourne based Pharmacist for the alleged unlawful advertising of nicotine vaping products.

The TGA is urging consumers to only purchase COVID-19 rapid antigen tests (RATs) that are approved for use in Australia to avoid the risk of poor test performance that could arise from using unapproved, repackaged or repurposed RATs.

The TGA has issued two infringement notices totalling $26,640 to a Sydney-based company for alleged unlawful advertising of a TENS device.

Consumers are advised to be cautious about ivermectin products that are sold by unverified online stores.

MEPH Pharmacy Pty Ltd fined $39,960 for the alleged unlawful advertising of nicotine vaping products

The TGA has issued an infringement notice for $2,664 to an individual for a NSW based herbal medicine practitioner for an alleged breach of the Advertising Code.

The TGA has granted provisional approval to AstraZeneca Pty Ltd for its tixagevimab and cilgavimab (EVUSHELD) for the prevention of COVID-19 in people who are at risk of infection but have not been exposed to the virus, known as pre-exposure prevention of COVID-19.

The TGA has issued two infringement notices totalling $5,328 to a Melbourne-based individual for alleged unlawful importation of nicotine vaping products.

The TGA has provisionally approved the Moderna CoVID-19 vaccine, SPIKEVAX, for use in individuals 6 years and older.

The TGA has issued an infringement notice of $13,320 to Victorian-based company TCF Trading Co Pty Ltd for alleged unlawful importation of COVID-19 rapid antigen tests.

JMIT Distributors Pty Ltd fined $79,920 for alleged advertising breaches of nicotine vaping products under the Therapeutic Goods Act 1989

NSW executive officer fined $10,656 for alleged advertising breaches of the Therapeutic Goods Act 1989 involving nicotine vaping products

The TGA has provisionally approved the AstraZeneca COVID-19 vaccine, Vaxzevria, for use as a booster in individuals aged 18 years and over.

The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use as a booster in individuals aged 16 and 17 years old.

No special exemptions to import or supply unapproved RATs

The TGA has granted provisional approval to two oral COVID-19 treatments.

On 19 January 2022 the TGA granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) in relation to the COVID-19 vaccine, NVX-CoV2373, for individuals aged 18 years and over.

The TGA determined that the two dose course of the Gamaleya Institute vaccine (Sputnik V, Russian Federation) would be 'recognised' for the purpose of establishing a traveller's vaccination status.

The TGA has issued an infringement notice, totalling $26,640, to Ezy Company Pty Ltd for alleged unlawful importation of COVID-19 rapid antigen tests and nicotine vaping products in breach of the Therapeutic Goods Act 1989.