Articles

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.

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

The Prescribing Medicines in Pregnancy database has now been updated.

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

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).

Medicines Safety Update - Information for health professionals

Medicines Safety Update - Information for health professionals

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.

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.