Outcomes of the court action against Oxymed Australia Pty Ltd

On 1 December 2021, the TGA granted provisional approval to Roche Products Pty Ltd for the use of tocilizumab (ACTEMRA) for the treatment of COVID-19.

The TGA has issued an infringement notice for $2,664 to an individual for an alleged breach of the Therapeutic Goods Act 1989 .

The TGA has issued seven infringement notices totalling $93,240 to Australia Utopia Pty Ltd for alleged unlawful advertising of nicotine vaping products on its website.

The Therapeutic Goods Administration (TGA) is making some important changes to the access framework and application processes for ' …

On 4 November 2021 the TGA granted provisional determination to AstraZeneca Pty Ltd in relation to the COVID-19 treatment tixagevimab and cilgavimab (EVUSHELD).

The TGA has issued three infringement notices, totalling $7,992, to a Melbourne-based individual for alleged importation breaches involving nicotine vaping products.

The TGA is warning consumers to be aware of counterfeit nicotine vaping products advertised and sold online.

The TGA has issued seven infringement notices totalling $18,648 to a Melbourne-based individual, for alleged unlawful advertising of nicotine vaping products

The TGA has issued seven infringement notices totalling $18,648 to the individual responsible for the Invigorate Labs website, for alleged breaches that relate to the advertising of products containing cannabidiol (CBD).

Lawyers for the TGA have written to United Australia Party leader, Mr Craig Kelly MP, alleging it has breached copyright and demanding that it stop distributing incomplete extracts of adverse event reports relating to COVID-19 vaccines which the TGA believes could be seriously misleading.

TGA has placed new restrictions on the prescribing of oral ivermectin

Joint statement from the TGA, Ahpra, Office of the Health Ombudsman and the Health Care Complaints Commission

On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare Australia Pty Ltd in relation to regdanvimab.

Ivermectin is a prescription medicine that is not approved in Australia (or in other OECD countries) to prevent or treat COVID-19 disease, and should not be imported for this indication.

The TGA has today approved for release doses of the Pfizer/BioNTech vaccine that arrived in Australia late last night from the Republic of Poland.

Users of nicotine vaping products are encouraged to make an appointment with their GP to discuss their smoking cessation options, ahead of changes from 1 October 2021.

On 9 August 2021 the TGA granted provisional approval to Moderna Australia Pty Ltd in relation to the COVID-19 vaccine, Spikevax (elasomeran), for individuals aged 18 years and over.

The Federal Court of Australia has ordered Evolution Supplements Australia and its Director to pay $12 million

The TGA has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims.

Joint ICMRA/WHO Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness.

The TGA, part of the Department of Health, has granted provisional determination to Moderna Australia Pty Ltd in relation to the COVID-19 Vaccine, Elasomeran

The TGA is seriously concerned about misleading information that has been broadcast on radio stations providing a distorted picture of the safety of COVID-19 vaccines.

The TGA has issued two infringement notices to Perth-based company V P & Associates Pty Ltd (V P & Associates), for alleged unlawful advertising of a medical device in relation to SARS-CoV-2 Human Coronavirus.

The TGA has issued two infringement notices to a dentist from Western Australia for the alleged unlawful importation of cosmetic injectables.

Peter Evans Chef Pty Ltd fined $79,920 for alleged unlawful advertising

Global Therapeutics Pty Ltd has paid penalties of $119,880 in response to nine infringement notices

Updated safety advisory - rare and unusual blood clotting syndrome (thrombosis with thrombocytopenia)

TGA has recently approved wider storage and transportation conditions for the Pfizer COVID-19 vaccine in Australia

TGA has issued two infringement notices for alleged unlawful advertising of a complementary medicine cancelled from the Australian Register of Therapeutic Goods.

The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the TGA this evening approving the release of the first four batches.

TGA has approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.

The TGA has issued four infringement notices for the alleged unlawful importation of infrared thermometers, rigid strapping tapes and iodine prep pads.

The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine

The TGA has concluded that there is no specific risk of vaccination with the Pfizer-BioNTech COVID-19 vaccine in elderly patients.

The TGA has issued eight infringement notices to Sydney-based company for allegedly failing to provide information and face mask samples to the TGA when required to do so, and for providing false and misleading information.

In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine