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

This consent is given under sections 14 and 14A of the Therapeutic Goods Act 1989.

This instrument is made under subsections 19(5AA), 32CM(1A) and 41HC(1A) of the Therapeutic Goods Act 1989.

This instrument is made under the Therapeutic Goods Regulations 1990, the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods Act 1989.

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.

We have issued infringement notices totalling $37,560 for the alleged unlawful possession of a commercial quantity of vaping goods.

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

The TGA and cooperating agencies have seized a large volume of alleged illicit vapes, tobacco and other substances in coordinated operations across Australia.

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

Find out about new requirements for labels of injectable electrolyte medicines and updates to guidance for medicine sponsors.

MRA GMP clearances that are expiring on 31 December 2024 will be automatically extended.

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.

We know that paracetamol is safe and effective for most people when taken at the recommended dose.

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

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

We are providing a 12-month period of labelling exemptions for signal words for certain Pharmacy medicine and Pharmacist Only medicine products.

We have introduced new features to improve your experience using Guidance on our website.

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.

The TGA has settled judicial review proceedings brought by InstantScripts in respect of infringement notices issued to it by the TGA.

In a significant move against the illicit vaping market, the TGA has played a vital role in joint enforcement activity with Victoria Police, resulting in the seizure of 200,000 vapes, worth more than $8 million

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

TGA has taken further action to combat the unlawful sale of vapes in Queensland, issuing an infringement notice to a retailer for the unlawful possession of a commercial quantity of vaping goods