Prescription medicines
Find out about prescription medicines and how they are regulated.
A prescription medicine is a medicine that can only be made available to a patient on the written instruction of an authorised health professional. Examples of prescription medicines include blood pressure tablets, cancer medicine and strong painkillers.
All prescription medicines are registered in the Australian Register of Therapeutic Goods (ARTG) and can be identified by an AUST-R number on the label.
Key information
- See the Australian Regulatory Guidelines for Prescription Medicines (ARGPM)
- For more detailed information on prescription medicines go to Prescription medicines overview.
- For information on obtaining market authorisation go to Supply a prescription medicine.
- For information on manufacture go to Manufacture a medicine.
- For a list of standards and guidelines go to Standards and guidelines for prescription medicines
- Search the Prescription medicines collection
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More prominent warnings are being added to the Product Information and Consumer Medicine Information for all oral and injectable (systemic) fluoroquinolones to strengthen existing warnings about serious side effects.
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Extra safety information is being added to all montelukast products to highlight the existing warnings about serious behaviour and mood-related changes
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Pharmacists can use a Serious Scarcity Substitution Instrument (SSSI) to dispense Protaphane Penfill human insulin in the place of a Protaphane InnoLet cartridge.
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TGA confirms decision to not register lecanemab (LEQEMBI)
Following a request from the sponsor to reconsider their decision, the TGA has confirmed the initial decision to not register the medicine on the basis that the safety and efficacy of the medicine were not satisfactorily established. -
Product Information safety updates - February 2025
Information for health professionals about medicines with safety related updates to their Product Information. -
Product Information safety updates - January 2025
Information for health professionals about medicines with safety related updates to their Product Information.
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Advisory Committee on Vaccines meeting Statement 49 for meeting held 2 October 2024
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Advisory Committee on Vaccines meeting statement for meeting 50 held 4 December 2024
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Advisory Committee on Vaccines Statement 51 for meeting held 5 February 2025