Articles

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.

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

2022 seasonal Influenza vaccines

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

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

Prevention notice under section 42DKB of the Therapeutic Goods Act 1989.

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

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.

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

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.

A new Therapeutic Goods Determination for listed medicine ingredients commences on 1 March 2022.

Medicines Safety Update - Information for health professionals

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