Articles

A new Therapeutic Goods Determination for listed medicine ingredients commences on 1 March 2022.

Medicines Safety Update - Information for health professionals

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

The TGA has granted provisional approval to AstraZeneca Pty Ltd for its tixagevimab and cilgavimab (EVUSHELD) for the prevention of COVID-19 in people who are at risk of infection but have not been exposed to the virus, known as pre-exposure prevention of COVID-19.

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

Medicines safety update - important information for health professionals

The TGA has granted provisional approval to AstraZeneca Pty Ltd for its tixagevimab and cilgavimab (EVUSHELD) for the treatment and prevention of COVID-19 in people who are at risk of infection but have not been exposed to the virus, known as pre-exposure prevention of COVID-19.

The TGA has issued two infringement notices totalling $5,328 to a Melbourne-based individual for alleged unlawful importation of nicotine vaping products.

Medicines Safety Update - Information for health professionals

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

The TGA has provisionally approved the Moderna CoVID-19 vaccine, SPIKEVAX, for use in individuals 6 years and older.

The TGA has issued an infringement notice of $13,320 to Victorian-based company TCF Trading Co Pty Ltd for alleged unlawful importation of COVID-19 rapid antigen tests.

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

JMIT Distributors Pty Ltd fined $79,920 for alleged advertising breaches of nicotine vaping products under the Therapeutic Goods Act 1989

NSW executive officer fined $10,656 for alleged advertising breaches of the Therapeutic Goods Act 1989 involving nicotine vaping products

The TGA has provisionally approved the AstraZeneca COVID-19 vaccine, Vaxzevria, for use as a booster in individuals aged 18 years and over.

The TGA has granted a second provisional determination to Gilead Sciences Pty Ltd in relation to its COVID-19 treatment, VEKLURY (remdesivir).

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

Medicines Safety Update - Information for health professionals

The TGA has provisionally approved the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for use as a booster in individuals aged 16 and 17 years old.

No special exemptions to import or supply unapproved RATs

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

Labelling exemption for COVID-19 Vaccine - Novavax.

TGA's safety monitoring of COVID-19 vaccines.

Acellur Dermal Matrix Products used in Breast Reconstruction - clarification on reports of potential higher complication rates.