Articles

Following a safety investigation into pholcodine the TGA are cancelling 55 products (from the ARTG) and recalling them from pharmacy shelves due to an increased risk of anaphylactic reactions.

This instrument is made under section 39 of the current Poisons Standard.

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

On 17 February, the TGA granted provisional approval to Moderna’s bivalent COVID-19 vaccine. This is the second bivalent vaccine targeting the Omicron BA.4-5 subvariants that has been provisionally approved by the TGA

The TGA are updating the Therapeutic Goods (Declared Goods) Order 2019 (Declared Goods Order) on 1 March 2023. This is the first time since 2020 that the Declared Goods Order has been amended to capture an update to WADA’s World Anti-Doping Code International Standard Prohibited List (Prohibited List).

In response to user feedback, we have been trialling a beta version of the DAEN – medicines since June 2022 alongside the older database.

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

Supplies of Ozempic (semaglutide) have begun distribution in Australia but will remain quite limited for some time.

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

Medicines Safety Update - Information for health professionals

The TGA has issued a direction notice to a Melbourne-based individual to cease advertising of all nicotine vaping products.

The TGA has today published an interim decision to reduce the maximum pack sizes for various paracetamol products.

From 1 July this year, medicines containing the psychedelic substances psilocybin and MDMA can be prescribed by specifically authorised psychiatrists for the treatment of certain mental health conditions.

The TGA has issued infringement notices to Caveman Nutrition Pty Ltd, The Cave Nutrition Store Pty Ltd and to the director of these companies for the alleged unlawful advertising of sports supplements and therapeutic goods not included in the ARTG.

The TGA has issued an infringement notice totalling $13,320 to Sydney company JSHealth Vitamins Pty Ltd for supplying a complementary medicine that allegedly did not conform with legal requirements.

The TGA has confirmed the performance of COVID-19 rapid antigen tests available on the Australian market with COVID-19 variants.

New guidelines and mandatory requirements for listed medicines ingredients have come into effect on 1 February 2023.

This instrument is made under subsection 26BD(3) of the Therapeutic Goods Act 1989.

Medicines Safety Update - Information for health professionals

The TGA has issued infringement notices to Mode Medical Pty Ltd for the alleged unlawful advertising to Australian consumers on a company website and social media.

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

This is the first vaccine provisionally approved by the TGA that is designed to specifically target the Omicron variants BA.4/BA.5 and follows provisional approval of the Pfizer BA.1 Omicron/original bivalent vaccine.

The TGA has commenced evaluation of an application from Moderna Australia Pty Ltd to transition its COVID-19 vaccine, SPIKEVAX, to full registration for the immunisation of individuals 6 years and over, and as a booster dose for individuals aged 12 years and older.

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

Current antibiotics shortages in Australia include amoxicillin, amoxicillin/clavulanic acid, cefalexin, metronidazole and trimethoprim.