A public assessment report, authored by the Australian regulator Therapeutic Goods Administration, that summarizes the evaluation and considerations of TGA in deciding to approve or not approve a marketing application for a prescription medicine. Whereas one EMA EPAR is written for each medicine, an AusPAR is created for a single marketing application, and is not updated following publication. Additional AusPARs are published for generic medicines, major variations and extensions of indications. The first AusPAR was published in Nov 2009. Also see European Public Assessment Report, Drug Approval Package
Also called AusPAR.
Example: AusPAR for Vytorin
Look up other AusPARs here
More information here
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