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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.

Introduction of requirements for sponsors of sartan medicines

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

The TGA has issued three infringement notices totalling $39,960 to Sydney-based company RV Global Ecommerce Pty Ltd for alleged unlawful advertising of nicotine vaping products.

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

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

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

The TGA determined that Covaxin (manufactured by Bharat Biotech, India) and BBIBP-CorV (manufactured by Sinopharm, China) vaccines would be 'recognised' for the purpose of establishing a traveller's vaccination status.

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 25 October 2021.

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

The TGA has provisionally approved a booster dose of the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for individuals 18 years and older.

The TGA is aware that, in Europe, atrioventricular blocks have been reported in patients receiving high doses of continuous intravenous infusion of octreotide and in patients receiving bolus octreotide intravenously.

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

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 commenced proceedings in the Federal Court against Enviro Tech Holdings Pty Ltd, and its executive officers for the alleged unlawful importation of surgical face masks.

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

On 15 October 2021 the TGA granted provisional approval to Roche Products Pty Ltd for its COVID-19 treatment - casirivimab + imdevimab (RONAPREVE) - making it the third COVID-19 treatment to receive regulatory approval in Australia.

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

The TGA granted provisional determination to Pfizer Australia Pty Ltd in relation to the COVID-19 Vaccine, COMIRNATY for use in children aged 5 to 11 years.

Health professionals are advised that the Product Information for pentosan polysulfate sodium has been updated with a warning about potential pigmentary maculopathy, especially after long-term use.

Questions to ask the overseas website before prescribing or purchasing a nicotine vaping product.

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

TGA has published a Joint statement on supply allocations of intravenous tocilizumab (Actemra) during serious shortage.

On 1 October 2021, the TGA granted provisional determination to Pfizer Australia in relation to a new combination medicine containing PF-07321332 and ritonavir, for the treatment of adult patients with symptomatic, confirmed coronavirus infection.