Articles

On 6 December 2021, the TGA granted provisional approval to Celltrion Healthcare Australia Pty Ltd for the use of regdanvimab (REGKIRONA).

New trial (beta) tool to search the Australian Register of Therapeutic Goods (ARTG) available.

TGA grants provisional approval to Celltrion Healthcare Australia Pty Ltd for COVID-19 treatment, regdanvimab (REGKIRONA)

The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use in individuals 5 years and older.

A new Therapeutic Goods Advertising Code has been made commencing 1 January 2022, with transition period

Outcomes of the court action against Oxymed Australia Pty Ltd

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

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 eight infringement notices totalling $106,560 to KL4 Pty Ltd (trading as Medcure), for the alleged importation of Ayurvedic medicines in breach of the Therapeutic Goods Act 1989 

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 three infringement notices totalling $7,992 to an individual for allegedly advertising ivermectin and zinc lozenges to treat COVID-19 in breach of the Therapeutic Goods Act 1989.

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

Legislative instrument made under 47B Provision of information concerning medicines, biologicals and medical devices.

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 provisionally approved the use of the Roche Products Pty Ltd combination therapy, casirivimab + imdevimab (RONAPREVE), for the treatment and prevention of COVID-19 in specific target populations.

The TGA has granted provisional determination to Grand Pacific CRO (the Australian sponsor acting on behalf of Medigen Vaccine Biologics Corp) in relation to its COVID-19 vaccine: MVC-COV1901-S-2P-Protein (MVC-COV1901 Vaccine).

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 TGA has issued eight infringement notices totalling $106,560 to Mason Online Pty Ltd for alleged unlawful advertising of nicotine vaping products.

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

The TGA has issued an infringement notice for $2,664 to a chiropractor from New South Wales for the alleged importation of ivermectin in breach of the Therapeutic Goods Act 1989.

The TGA has issued four infringement notices, totalling $53,280, for the alleged export, supply and advertising of counterfeit erectile dysfunction (ED) medicines in breach of the Therapeutic Goods Act 1989.

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

The TGA has granted a provisional determination to Moderna Australia Pty Ltd in relation to its COVID-19 vaccine, SPIKEVAX.

The TGA has identified certain therapeutic goods being inappropriately promoted for the prevention or treatment of novel coronavirus (2019-nCoV) infections in Australia

Introduction of requirements for sponsors of sartan medicines