Articles

There may be an increased risk of neurodevelopmental disorders in children born to men who have taken sodium valproate in the 3 months before conception.

Following a request from the sponsor to reconsider their decision, the TGA has confirmed the initial decision to not register the medicine on the basis that the safety and efficacy of the medicine were not satisfactorily established.

We are updating information for nitrosamine impurities and other nitroso-structure impurities in medicines including acceptable intakes (AI)

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

Australians who use tanning products containing ‘melanotan’ are at risk of serious health problems.

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

Additional safety information is being added to all montelukast products to strengthen and highlight existing warnings about serious neuropsychiatric events.

The defendant faces a maximum penalty of 12 months’ imprisonment and/or a fine of up to $222,000 for each charge.

Recall reforms program update and preview of the PRAC Version 1.0.

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

If your business sells or advertises paracetamol, then you need to be aware of the new rules around pack sizes that commence on 1 February 2025.

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

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.

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.

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

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

One of the key functions of the Therapeutic Goods Administration (TGA) is to closely monitor the safety of therapeutic goods. But to properly monitor safety, we need everyone to report any side effects and problems they have.

The Product Information (PI) documents for antidepressants have been updated with warnings about sexual dysfunction continuing in some patients, after they stop using the medicines.

The second phase of the Recall Reforms Program is now being implemented. Updated processes will reduce regulatory burden for sponsors while maintaining public safety.

If you use a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine you may be affected by this recall action. Register your machine for repair or replacement to avoid any potential risks.

In line with the official end of the COVID-19 emergency response, this will be our last regular COVID-19 Vaccine Safety Report. We will continue safety monitoring of COVID-19 vaccines.

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

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

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