Articles

On 10 July 2020 the Therapeutic Goods Administration (TGA) granted provisional approval to remdesivir ("Veklury", Gilead Sciences Pty Ltd) as the first treatment option for COVID-19

On 20 August 2021 the TGA granted provisional approval to GlaxoSmithKline Australia Pty Ltd in relation to sotrovimab (XEVUDY).

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).

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

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.

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

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).

The TGA has now approved an application from the sponsor for an extension of shelf-life to 18 months when stored at 2°C to 8°C.

Medicines Safety Update - Information for health professionals

Medicines Safety Update - Information for health professionals

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

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

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.

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

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