Articles

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.

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

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

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.

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

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.

Health professionals are advised that the Product Information (PI) documents for methylphenidate products have been updated with new information about use in pregnancy.

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

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

This instrument is made under subregulations 4A.2(4) of the Therapeutic Goods (Medical Devices) Regulations 2002.

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

Joint ICMRA/WHO Statement for healthcare professionals: How COVID-19 vaccines are regulated for safety and effectiveness.

Information for health professionals

The TGA has issued seven infringement notices totalling $93,240 to Melbourne-based global biopharmaceutical company Starpharma Holdings Limited (Starpharma), for alleged illegal advertising of a nasal spray that is not approved for use in Australia.

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

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

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