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

The TGA has granted a provisional determination to Pfizer's bivalent COVID-19 vaccine candidate: tozinameran & famtozinameran (COMIRNATY BIVALENT OMICRON BA.4/BA.5 COVID-19 VACCINE).

Arrangement under subsection 7C(1) of the Therapeutic Goods Act 1989 for use of computer programs to make decisions under sections 61(3)(a), 61(5AA), and 61(5AB) of the Act

On 25 October 2022, Natural Franchises Pty Ltd pleaded guilty in a Sydney court to over 200 offences of the Therapeutic Goods Act 1989 for the manufacture, supply and advertising of unapproved therapeutic goods.

The TGA is calling for anyone using a Philips Continuous Positive Airway Pressure (CPAP) machine or a Bi-level Positive Airway Pressure (Bi-Level PAP) machine to see if they are affected by the recall action.

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Vaccine - Pfizer) (Tozinameran and Riltozinameran) Labelling Exemption 2022.

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

Find out about the requirements starting on 1 January 2023 for medicines that are serialised or include a data matrix code.

The TGA has issued one infringement notice to Queensland-based IMUNI Pty Ltd for allegedly advertising a complementary medicine for a therapeutic use that was not permitted.

Medicines Safety Update - Information for health professionals.

The TGA has issued infringement notices for the alleged unlawful advertising of medicinal cannabis products on a website and through social media.

The TGA has issued infringement notices for the alleged unlawful advertising of medicinal cannabis products on their websites and social media platforms.

The TGA has provisionally approved Pfizer’s bivalent COVID-19 vaccine, tozinameran and riltozinameran (COMIRNATY Original/Omicron BA.1) for use as a booster dose in adults 18 years and over.

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

On 19 October 2022, the TGA provisionally approved Moderna's COVID-19 vaccine, SPIKEVAX (elasomeran), for use as a booster dose in individuals aged 12 years and older.

Inspire Cosmetology Pty Ltd fined $26,640 for alleged unlawful import of cosmetic injectable products

NSW medical practitioner fined for allegedly illegally importing prescription medicines

The Pharmacovigilance Inspection Program (PVIP) Risk Assessment Survey is now open until 18 December 2022 for medicine sponsors to complete.

The TGA has issued two infringement notices totalling $5,328 to a Queensland-based individual for the alleged unlawful use of a prohibited representation and endorsement in advertising a listed complementary medicine.

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

Tell us your experience using of the beta Database of Adverse Event Notifications (DAEN) - medicines.

Medicines Safety Update - Information for health professionals

The TGA has granted a provisional determination to Moderna Australia Pty Ltd’s bivalent COVID-19 vaccine candidate: elasomeran and davesomeran (SPIKEVAX BIVALENT ORIGINAL/OMICRON BA.4/BA.5)

The TGA has provisionally approved a paediatric dose of Pfizer’s COVID-19 vaccine, COMIRNATY (tozinameran), for children aged 6 months to less than 5 years

Direction and infringement notices given to MDNE Enterprises Pty Ltd for alleged unlawful advertising of nicotine vaping products