Articles

Health professionals and consumers are advised that the oral antihistamine promethazine hydrochloride, sold as Phenergan and other generic brands, should not be used in children under 6 years of age.

We have received Australian reports of Guillain-Barré Syndrome (GBS) following Shingrix vaccination.

Information for health professionals about medicines with safety related updates to their Product Information.

TGA has made the decision not to register lecanemab (LEQEMBI) for the treatment of patients with Mild Cognitive Impairment (MCI) due to Alzheimer's disease and Mild Alzheimer's dementia (early Alzheimer's disease).

The TGA is updating information for nitrosamine impurities in medicines including acceptable intakes (AI).

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

From 28 October 2024, Telstra and Optus are switching off their 3G networks. Medical devices and products like personal medical alarms could be affected by these closures.

The Prescription Medicines in Pregnancy database has been updated to include new and amended entries.

Information for health professionals about medicines with safety related updates to their Product Information.

The TGA is working with participating businesses to arrange the surrender of their vaping goods.

Two new quality standards, one for MDMA and another for psilocybine, have been published.

Information for health professionals about medicines with safety related updates to their Product Information.

The TGA has been reviewing the safety and performance of spinal cord stimulator (SCS) devices.

A reminder about financial deadlines that are approaching for sponsors and manufacturers.

Some changes are rolling out soon to improve your experience using guidance on our website. We’re aiming to make our content clearer, more accessible and easier to navigate.

Some medical device equipment could soon be affected as mobile network operators prepare to switch off their 3G networks.

An updated warning about the risk of sudden cardiovascular death has been added to the Product Information and Consumer Medicine Information documents for azithromycin.

We are advising sponsors of updates to the Generic Medicines Work-Sharing Initiative (GMWSI) operational procedures.

Following an extensive internal and external consultation process, we have adopted the following 13 international scientific guidelines.

The TGA is updating acceptable intake information for nitrosamine impurities in medicines.

Information for health professionals about medicines with safety related updates to their Product Information.

The Scheme allows businesses to surrender certain quantities of vaping goods that were lawful prior to 1 July 2024. Notify us before September 2024 to participate.

Find out about regulatory changes to a range of medical devices and application audit requirements.

Medicines Safety Update - Information for health professionals

Prescription lenses supplied only for refractive correction are now exempt from inclusion in the Australia Register of Therapeutic Goods (ARTG) prior to import, export or supply in Australia.