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Individual fined $2,664 for unlawful importation of nicotine vaping pods

On 7 April 2022, the TGA announced receipt of an application from GlaxoSmithKline (GSK) Australia Pty Ltd for a higher (1000 mg) dose of its COVID-19 treatment, XEVUDY (sotrovimab).

The TGA has granted provisional approval to Gilead Sciences Pty Ltd to extend the use of the COVID-19 treatment, VEKLURY (remdesivir).

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.

On 27 April 2022 the TGA granted a provisional determination to Moderna Australia Pty Ltd in relation to its bivalent COVID-19 vaccine, elasomeran/elasomeran 0-omicron (SPIKEVAX Bivalent Zero/Omicron).

CheckMe Pty Ltd fined $13,320 for unlawful import of COVID-19 test kits

G1 Resources Pty Ltd fined for alleged unlawful importation and advertising of unapproved rapid antigen tests

Cat Media Pty Ltd fined $39,960 for allegedly advertising unregistered Fatblaster weight-loss products

Dentist fined $5,328 for alleged unlawful importation of botox

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.

The TGA has issued an infringement notice of $13,320 for alleged breaches of therapeutic goods legislation in relation to pharmacovigilance.

The TGA has issued an infringement notice of $13,320 for alleged breaches of therapeutic goods legislation in relation to pharmacovigilance.

The TGA has received an application from GlaxoSmithKline (GSK) Australia Pty Ltd for a higher (1000 mg) dose of its COVID‑19 treatment, sotrovimab (XEVUDY)

Listed medicine ingredients and requirements are updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 3) 2022.

Transition to the mandatory statement requirements of the 2021 Advertising Code

Shen Neng Herbal Medicines Group Pty Ltd fined $53,280 for alleged breaches of therapeutic goods legislation.

Six monthly report – supply of unapproved therapeutic goods by a sponsor.

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.

Prevention notice under section 42DKB 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.