Prescription medicines: new registrations

TGA publishes information on new prescription medicines as they are approved. This includes entirely new medicines (termed 'new chemical or biological entities'), extended uses ('extensions of indications') or new combinations of already registered medicines, and new generic or biosimilar medicines. Once approved, these medicines are added to the Australian Register of Therapeutic Goods (ARTG) and are available for supply in Australia to be prescribed by healthcare professionals for specific indications. The decision to approve these medicines follows a comprehensive review by TGA scientists and clinicians on the quality, safety and efficacy of the proposed use of the medicine.

Details of registrations of new prescription medicines are below – please select according to category. Please note that the trade name, active ingredient, and sponsor for each medicine reflect the information initially entered in the ARTG at the time of registration, and may change at a later date. Please consult the ARTG for full information in relation to these products, including full indications.