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

Conducting domestic inspections during the Coronavirus (COVID-19) pandemic

Ivermectin is a prescription medicine that is not approved in Australia (or in other OECD countries) to prevent or treat COVID-19 disease, and should not be imported for this indication.

On 20 August 2021 the TGA granted provisional determination to Roche Products Pty Ltd in relation to the combination therapy casirivimab + imdevimab (RONAPREVE)

On 20 August 2021 the TGA granted provisional determination to Celltrion Healthcare Australia Pty Ltd in relation to regdanvimab.

The Therapeutic Goods (Permissible Ingredients) Determination has been updated.

On 20 August 2021 the TGA granted provisional approval to GlaxoSmithKline Australia Pty Ltd in relation to sotrovimab (XEVUDY).

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

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.

The TGA has approved AstraZeneca's submission to change the name of its COVID-19 Vaccine AstraZeneca to VAXZEVRIA.

Overview of TGA rules on advertising nicotine vaping products, outlining restricted permissions for pharmacies and strict limits on content, format, and promotion channels to protect public health.

The TGA has today approved for release doses of the Pfizer/BioNTech vaccine that arrived in Australia late last night from the Republic of Poland.

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

Users of nicotine vaping products are encouraged to make an appointment with their GP to discuss their smoking cessation options, ahead of changes from 1 October 2021.

On 9 August 2021 the TGA granted provisional determination to Merck Sharp & Dohme (Australia) Pty Ltd (MSD) in relation to Molnupiravir.

The Minamata Convention facilitates a global approach to address concerns relating to mercury, which is persistent, toxic and highly mobile in the environment once released, and recognised as a substance producing significant neurological and other effects in humans.

On 9 August 2021 the TGA granted provisional approval to Moderna Australia Pty Ltd in relation to the COVID-19 vaccine, Spikevax (elasomeran), for individuals aged 18 years and over.

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

The TGA has issued twenty infringement notices totalling $266,400 to a Canberra-based dental practice.

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

The Federal Court of Australia has ordered Evolution Supplements Australia and its Director to pay $12 million

The TGA has issued four infringement notices totalling $10,656 to a Sydney-based individual, for alleged unlawful advertising of Cannabidiol Oil in breach of the Therapeutic Goods Act 1989.

Product Information documents for parenteral iron products are currently being updated to include information about fetal bradycardia and Kounis syndrome.

The Product Information for nifedipine has been updated to provide new information about the risk of acute pulmonary oedema when used as a tocolytic agent (inhibiting myometrial smooth muscle contractions) for the treatment of preterm labor in pregnancy.