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- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - Gilead) (Remdesivir) Labelling Exemption 2021NoticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- TGA commences evaluation of Moderna COVID-19 vaccine (SPIKEVAX) for potential transition to full registrationMedia releasesThe TGA has commenced evaluation of an application from Moderna Australia Pty Ltd to transition its COVID-19 vaccine, SPIKEVAX, to full registration for the immunisation of individuals 6 years and over, and as a booster dose for individuals aged 12 years and older.
- Therapeutic Goods (Poisons Standard) (COVID-19 Treatment - GlaxoSmithKline) (Sotrovimab) Labelling Exemption 2021NoticesThis labelling exemption is granted under section 1.5.5 of Part 2 of the current Poisons Standard.
- Travellers with injectable medicines containing ingredients derived from animal or human origin no longer require TGA approval to enter AustraliaMedia releasesTravellers will be able to bring up to 3-months supply of their medicine.
- Therapeutic Goods (Biologicals-Application Form for Priority Applicant Determinations) Approval 2022NoticesApproval of the Therapeutic Goods (Biologicals—Application Form for Priority Applicant Determinations)
- Media releasesThe TGA has issued an infringement notice of $2,664 to a NSW-based medical practitioner for alleged unlawful advertising of nicotine vaping products in a social media post.
- TGA grants provisional determination to Pfizer’s COVID-19 bivalent (COMIRNATY BIVALENT OMICRON BA.4/BA.5) booster dose vaccineMedia releasesThe 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).