Tag Archives: TGA

Vaporisers pass the TGA smoke screen

The Therapeutic Goods Administration (TGA) has this week approved the registration of a range of medically approved vaporisers in Australia. The approval of the Storz & Bickel GmbH & Co. KG medical standard vaporisers has been welcomed by Spectrum Therapeutics Australia (Spectrum), the medical division of Canopy Growth Corporation Australia …

Read More »

Therapy for multiple myeloma patients TGA approved

Multiple Myeloma

A novel triplet therapy for newly diagnosed multiple myeloma (NDMM) patients is now Therapeutic Goods Administration (TGA) approved. Revlimid (lenalidomide), in combination with bortezomib and dexamethasone (RVd), is now indicated for the treatment of patients with previously untreated multiple myeloma. The medication is an immunomodulating agent that inhibits the proliferation …

Read More »

New e-learning modules for pharmacists

The Pharmaceutical Society of Australia (PSA) and the Pharmacy Guild of Australia (Guild), in partnership with the Therapeutic Goods Administration (TGA) have developed two new e-learning modules for pharmacists. The e-learning modules are said to be designed to help pharmacists increase their knowledge of the regulatory requirements applied to complementary …

Read More »

Modified-release paracetamol now pharmacist only (Schedule 3)

The TGA has upheld the decision to up-schedule modified-release paracetamol from pharmacy medicine (Schedule 2) to pharmacist only medicine (Schedule 3). The implementation date for the change is reportedly June 1, 2020. From then pharmacists will be required to move all products containing modified-release paracetamol (665mg), including Panadol Osteo, behind …

Read More »

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 …

Read More »

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 …

Read More »

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). • …

Read More »

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 …

Read More »

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 …

Read More »