Tag Archives: TGA

M for Empty

From February, an empty appendix has appeared in the Poisons Standard. Appendix M initially promised much, but today, all it contains is a heading that says, “Additional controls or supply requirements for poisons included in Schedule 3 to allow them to be provided by a pharmacist”. Other than that, it …

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TGA approves new weight loss medication

Contrave, a dual acting oral weight loss medication which helps control hunger and cravings has been approved by the TGA. It is the first combination of naltrexone – an opioid antagonist, and bupropion – a dopamine and noradrenaline reuptake inhibitor, both of which are approved and have been in use …

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APO-Valsartan product recall

Apotex, in consultation with the TGA, is recalling all batches and strengths of the company’s supplied APO-Valsartan tablet blister packs due to the presence of trace elements of an impurity. The products being recalled comprise: • APO-Valsartan 40mg tablets (AUST R 185806). • APO-Valsartan 80mg tablets (AUST R 185814). • …

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TGA alleges peptide claims are false

TGA instigates legal action against Peptide Clinics Australia for advertising compounded prescription-only therapeutic goods to the general public without the necessary approvals. The TGA has uncovered breaches of the Therapeutic Goods Advertising Code 2015 (the Code) and the Therapeutic Goods Act 1989 following an investigation. The advertisements were accessible to registered …

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Pholcodine has a well-established favourable safety profile

The Australian Self Medication Industry (ASMI) is seeking to reassure Australians that cough and cold medicines containing pholcodine have a long history of use and a well-established favourable safety profile. Pholcodine is used as a common cough suppressant and is an active ingredient in some cough and cold products available …

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Mandatory reporting of medicine shortages

The Pharmacy Guild has welcomed the passing of legislation to make the reporting of essential-medicine shortages mandatory. The legislation, which comes into effect on January 1, 2019, also provides an opportunity for PBS coverage of alternative medicines when there are shortages. Medicine shortages have become an increasing problem in recent …

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TGA on ED and sunscreens

The TGA is asking consumers to consult their doctor ahead of buying medicines for erectile dysfunction (ED) from overseas websites. The organisation says there are no safety, quality or efficacy guarantees for medicines bought from overseas. Medicines for ED may contain the active ingredient sildenafil, tadalafil or vardenafil and can …

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Cannabis online tool

The TGA has introduced an online tool aimed at reducing the administrative burden on health practitioners applying for approval to prescribe unregistered medicines such as medicinal cannabis. The TGA says the pathway to prescribing medicinal cannabis legally for a patient, the Special Access Scheme Category B (SAS B) online system …

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