Articles

The TGA granted provisional approval to Janssen-Cilag Pty Ltd (known as Johnson & Johnson overseas) for its COVID-19 vaccine Janssen, making it the third COVID-19 vaccine to receive regulatory approval in Australia.

The TGA, part of the Department of Health, has granted provisional determination to Moderna Australia Pty Ltd in relation to the COVID-19 Vaccine, Elasomeran

The granting of this determination means that Pfizer is now eligible to apply to vary its provisional registration for the vaccine for use in individuals 12 years of age or older.

The granting of a provisional determination means that the TGA has made a decision that GSK is now eligible to apply for provisional registration for the treatment in the Australian Register of Therapeutic Goods.

The Melbourne-manufactured AstraZeneca vaccine is now available for Australians, with the TGA this evening approving the release of the first four batches.

TGA has approved manufacture of the AstraZeneca COVID-19 Vaccine (ChAdOx1-S) in Australia.

The TGA has granted provisional approval to AstraZeneca Pty Ltd for its COVID-19 vaccine

The TGA has concluded that there is no specific risk of vaccination with the Pfizer-BioNTech COVID-19 vaccine in elderly patients.

In recent days the TGA has received reports of about 30 deaths in over 40,000 elderly individuals in Norway vaccinated with the Pfizer BioNTech vaccine

Today the TGA announced a final decision to down-schedule certain low dose cannabidiol (CBD) preparations

The TGA notes the emergency use authorisation related to the COVID-19 vaccine BNT162b2 supplied by Pfizer and BioNTech.

On 16 November 2020 the TGA granted a provisional determination to Janssen in relation to its COVID-19 vaccine, Ad26.COV2.S.

The TGA has granted a provisional determination to Pfizer Australia Pty Ltd in relation to its COVID-19 Vaccine, BNT162b2 [mRNA]

The TGA has granted a provisional determination to AstraZeneca Pty Ltd in relation to its COVID-19 Vaccine, ChAd0x1-S [recombinant]

The Australian Government has given approval to proceed with two measures to enhance transparency for prescription medicines

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 41FDB, 41FF and 41FH of the Act

TGA has launched the new Early Scientific Advice service, allowing applicants to request advice on biowaiver justifications

Information on generic prescription medicines

No lasting increase in consumption following up-scheduling of low-dose products

The reforms will enable the safe and effective prescribing and use of opioids while maintaining access for patients who need them.

How to find information about the inactive ingredients in your medicines.

Xofluza approved as part of an international work-sharing initiative between the TGA, Health Canada and Swissmedic

Measles vaccine testing shows the vaccine meets required standards

A new S41BD(3) instrument has been signed to declare that some nappy rash products are not to be medical devices for the purposes of the Act

Acalabrutinib receives approval through the second international collaborative review initiative between the TGA, FDA and Health Canada