Articles

Medicines Safety Update - Information for health professionals

The TGA has granted a second provisional determination to Gilead Sciences Pty Ltd in relation to its COVID-19 treatment, VEKLURY (remdesivir).

Medicines Safety Update - Information for health professionals

Acellur Dermal Matrix Products used in Breast Reconstruction - clarification on reports of potential higher complication rates.

Medicines Safety Update - Information for health professionals

On 18 January 2022 the TGA granted provisional approval to Merck Sharp & Dohme (Australia) Pty Ltd for its oral COVID-19 treatment, LAGEVRIO (molnupiravir).

On 18 January 2022 the TGA granted provisional approval to Pfizer Australia Pty Ltd’s oral COVID-19 treatment nirmatrelvir + ritonavir (PAXLOVID).

Medical device safety update regarding pulse oximeters limitations, including the effect of skin pigmentation.

Medicines Safety Update - Information for health professionals

The new Therapeutic Goods (Medicines Advisory Statements) Specification 2021 commences 1 January 2022

Medicines Safety Update - Information for health professionals

An overview of the regulation of Personal Protective Equipment (PPE) in Australia, including face masks, gowns and gloves

On 6 December 2021, the TGA granted provisional approval to Celltrion Healthcare Australia Pty Ltd for the use of regdanvimab (REGKIRONA).

On 1 December 2021, the TGA granted provisional approval to Roche Products Pty Ltd for the use of tocilizumab (ACTEMRA) for the treatment of COVID-19.

The TGA is aware that, in Europe, atrioventricular blocks have been reported in patients receiving high doses of continuous intravenous infusion of octreotide and in patients receiving bolus octreotide intravenously.

On 15 October 2021 the TGA granted provisional approval to Roche Products Pty Ltd for its COVID-19 treatment - casirivimab + imdevimab (RONAPREVE) - making it the third COVID-19 treatment to receive regulatory approval in Australia.

The TGA granted provisional determination to Pfizer Australia Pty Ltd in relation to the COVID-19 Vaccine, COMIRNATY for use in children aged 5 to 11 years.

Health professionals are advised that the Product Information for pentosan polysulfate sodium has been updated with a warning about potential pigmentary maculopathy, especially after long-term use.

Questions to ask the overseas website before prescribing or purchasing a nicotine vaping product.

Medicines Safety Review

On 28 March 2018, the Senate Community Affairs References Committee reported on its inquiry into the number of women in Australia who have had transvaginal mesh implants and related matters - external site.

Medicines Safety Review

Changes enhance transparency

The TGA is inviting consumers, health professionals, industry and other stakeholders to share their views in our annual stakeholder survey by 27 August 2021.