Articles

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

Risk of Guillain-Barre syndrome added to Product Information.

Updated illustrations clarify how to use measuring syringe for oral solutions.

Like all goods available in Australia, therapeutic goods can sometimes experience problems. When this happens, we decide if a ‘market action’ is needed. A market action aims to correct the problem. There are four types of market actions you should be aware of.

Complementary medicines are therapeutic goods that are often derived from traditional medicine practices. They can usually be purchased from supermarkets, health stores and pharmacies without seeing a doctor or pharmacist.
However, just because a medicine is available without a prescription, or claims to be ‘natural’ or ‘healthy’, doesn’t mean it’s safe for you.

While we encourage health practitioners to prescribe approved therapeutic goods where possible, unapproved therapeutic goods can be accessed in limited circumstances.
In making these joint decisions to use an unapproved therapeutic good, your doctor is required to inform you of the potential benefits and risks.

Updated information for nitrosamine impurities in medicines consistent with recent EMA updated information.

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

Updates further highlight potential risks of mood-related changes and sexual disorders.

Update on the progress in reducing the backlog of GMP Clearance Compliance Verification (CV) applications.

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

More prominent warnings are being added to the Product Information (PI) and Consumer Medicine Information (CMI) for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects

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.

TCMs sold in Australia are carefully regulated to ensure safety and quality.

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.