Articles

The TGA has cancelled the listed complementary medicine FatBlaster Max (AUST L 348163) from the Australian Register of Therapeutic Goods (ARTG) for alleged breaches of the Therapeutic Goods Act 1989.

TMF Cosmeceuticals Pty Ltd fined $26,640 for alleged unlawful importation of ivermectin

The TGA has issued three infringement notices totalling $39,960 to New South Wales based company Khazanah Nasional Pty Ltd for alleged unlawful advertising of disposable liquid nicotine vaping products.

Aussiewhip Pty Ltd fined $39,960 for alleged unlawful advertising of disposable nicotine vaping products

The TGA has issued one infringement notice of $2,664 to a Sydney based individual for alleged unlawful importation of unregistered anaesthetic products.

The TGA has determined that the BBIBP-CorV (Sinopharm) COVID-19 vaccine will be 'recognised' for all ages for the purpose of establishing a traveller's vaccination status when entering Australia.

The TGA has received and commenced evaluation of an application to extend the use of its COVID-19 vaccine, SPIKEVAX, to children aged 6 months to 5 years old.

FuturePro was convicted and released on recognisance, its directior was convicted and fined $25,000.

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.