Articles

Provisional registration of Tecentriq (atezolizumab) for the treatment in mTNBC will lapse on 22 March 2023.

More applications for Good Manufacturing Practice (GMP) clearances can now be assessed under the TGA’s MRA pathway.

Health professionals should check if patients undergoing general anaesthesia have used products containing pholcodine in the previous 12 months.

The TGA has issued an infringement notice for $13,320 to Sydney company JSHealth Vitamins Pty Ltd for an alleged breach of the Therapeutic Goods Act 1989.

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

The TGA has issued 12 infringement notices totalling $159,840 to a manufacturer of listed complementary medicines after a recent inspection of the company’s premises identified unacceptable manufacturing practices.

On 22 February the TGA, with the assistance of NSW Police, executed 3 search warrants connected to an individual operating in the Newcastle area of New South Wales.

The TGA is aware of concerns about decreased effectiveness of monoclonal antibodies against the COVID-19 caused by emerging SAR-COV-2 variants. At this stage, the regulatory status of the products remain unchanged in Australia.

Medicines Safety Update - Information for health professionals

Listed medicine ingredients and requirements for their use have been updated in the Therapeutic Goods (Permissible Ingredients) Determination (No. 1) 2023.

The TGA is aware of several scams targeting consumers seeking semaglutide (Ozempic). Consumers are strongly advised not to use products unless they have come from a trusted source.

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.