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Medicines Safety Update - Information for health professionals

Labelling exemption for COVID-19 Vaccine - Novavax.

Acellur Dermal Matrix Products used in Breast Reconstruction - clarification on reports of potential higher complication rates.

Medicines Safety Update - Information for health professionals

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 18 January 2022.

This instrument is the Therapeutic Goods (Poisons Standard) (COVID-19 Treatment—Merck Sharp and Dohme) (Molnupiravir) Labelling Exemption 2022.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

Medical device safety update regarding pulse oximeters limitations, including the effect of skin pigmentation.

Medicines Safety Update - Information for health professionals

The TGA granted provisional determination to Vaxine Pty Ltd in relation to their COVID-19 vaccine, Recombinant CoV-2-S-ΔTM protein with Advax-CpG55.2.

Medicines Safety Update - Information for health professionals

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

This is the new the legislative instrument, Therapeutic Goods (Six Monthly Report Form - Sponsor) Approval 2021 to be published on the TGA website. It is for the Six monthly report – supply of unapproved therapeutic goods by a sponsor.

Legislative instrument made under 47B Provision of information concerning medicines, biologicals and medical devices.

The TGA has granted provisional determination to Grand Pacific CRO (the Australian sponsor acting on behalf of Medigen Vaccine Biologics Corp) in relation to its COVID-19 vaccine: MVC-COV1901-S-2P-Protein (MVC-COV1901 Vaccine).

Introduction of requirements for sponsors of sartan medicines

A new Therapeutic Goods Determination for listed medicine ingredients commenced on 25 October 2021.

The TGA has provisionally approved a booster dose of the Pfizer Australia Pty Ltd COVID-19 vaccine, COMIRNATY, for individuals 18 years and older.

The TGA is aware that, in Europe, atrioventricular blocks have been reported in patients receiving high doses of continuous intravenous infusion of octreotide and in patients receiving bolus octreotide intravenously.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

Health professionals are advised that the Product Information for pentosan polysulfate sodium has been updated with a warning about potential pigmentary maculopathy, especially after long-term use.

This labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.

Medicines Safety Review

Information about the Senate inquiry into the ‘Number of women in Australia who have had transvaginal mesh implants and related matters.’