Articles

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

Medicines Safety Update - Information for health professionals

The TGA has granted provisional approval to two oral COVID-19 treatments.

On 19 January 2022 the TGA granted provisional approval to Biocelect Pty Ltd (on behalf of Novavax Inc) in relation to the COVID-19 vaccine, NVX-CoV2373, for individuals aged 18 years and over.

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 18 January 2022.

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Treatment—Merck Sharp and Dohme) (Molnupiravir) Labelling Exemption 2022.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

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).

The TGA determined that the two dose course of the Gamaleya Institute vaccine (Sputnik V, Russian Federation) would be 'recognised' for the purpose of establishing a traveller's vaccination status.

The TGA has issued an infringement notice, totalling $26,640, to Ezy Company Pty Ltd for alleged unlawful importation of COVID-19 rapid antigen tests and nicotine vaping products in breach of the Therapeutic Goods Act 1989.

Information about the TGA's safety monitoring of COVID-19 vaccines.

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

Information about the TGA's safety monitoring of COVID-19 vaccines.

Medicines Safety Update - Information for health professionals

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

On 4 January 2022 the TGA granted a further provisional determination to AstraZeneca Pty Ltd in relation to the COVID-19 treatment tixagevimab and cilgavimab (EVUSHELD).