Articles

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

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

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

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

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

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.

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.

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.

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.

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.

The Product Information for ocrelizumab has been updated to include a warning and further information about late onset neutropenia.

PI used by healthcare professionals updated

The TGA has issued an infringement notice for $2,664 to an individual from Canberra, for a breach of the Therapeutic Goods Act 1989 in relation to the alleged unlawful advertising of a homoeopathic medicine with COVID-19 claims.

The TGA has provisionally approved the use of the Pfizer BNT162b2 COVID-19 vaccine (COMIRNATY) in individuals 12 years and older.