Articles

An amendment to the Therapeutic Goods (Permissible Ingredients) Determination commenced on 2 September 2019.

Medicines Safety Update article

Direction Notice issued to cease advertising of therapeutic goods not entered in the ARTG

Direction Notice issued to cease advertising of unregistered therapeutic goods to consumers

Safety information: regulators review balloon and stent devices used to unblock blood vessels in the legs

Medicines Safety Update article

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

Medicines Safety Update article

Direction Notice issued to cease advertisement of prescription and illegal products

Infliximab and mycosis fungoides, infliximab and lupus-like syndrome, and medicine shortages mandatory reporting

TGO 100 has been registered on the Federal Register of Legislation. It commences on 8 December 2018, repealing and replacing TGO 98

Standards minimise risk of misconnections; eltrombopag interference with test results; amniotic fluid tests

Case studies in Incident Report Investigations; review of reusable biopsy forceps devices; care required with patient lifters

New warning labels for neuromuscular blocking agents; local anaesthetic systemic toxicity; off-label use of atropine

TGA issues advertising direction

The TGA completed a desktop review of selected listed sunscreen products.

Be aware of cross-reactivity with home-use self-test ovulation kits, TGA undertakes product safety review into intragastric balloon systems

Oral methotrexate dosing, medicines associated with a risk of neuropsychiatric adverse events, and clozapine and gastrointestinal effects

This instrument applies to an application to list a complementary medicine under section 26AE of the Act.

This instrument applies to an application to list a medicine under section 26 or 26A of the Act.

This instrument applies to an application to register a complementary medicine

How TGA uses joint replacement registry data; Focus on skills for vacuum-assisted births; TGA reviews product safety of ventilators

Therapeutic Goods (Provisional Determinations and Orphan Drug Designations-Extension) Approval of Application Form.

This instrument applies to the online form titled Prescription Medicines Designation/Determination Application in the TGA's electronic lodgement facility, completed in accordance with the relevant instructions in that form.

First-generation oral sedating antihistamines – use in children, Suvorexant (Belsomra) – next day effects, Desvenlafaxine (Pristiq) recommended dose, Miconazole and potential interaction with warfarin