Australian Public Assessment Reports for prescription medicines (AusPARs)
An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the TGA to approve or not approve an application.
Before a prescription medicine can be made available in Australia, the company legally responsible for supplying the product must lodge a submission with the TGA. The TGA then evaluates the safety, quality and effectiveness of the product to determine if the benefits to people taking the medicine outweigh the risks.
If a company wants to change something about the medicine once it is available, they also need to lodge a submission for the TGA to evaluate.
Please be aware that the AusPAR contains the Product Information for that prescription medicine at the time the TGA evaluated it. Product Information may have been updated since the AusPAR was prepared. For the current Product Information for a medicine please see: Product Information (PI).
The format of AusPARs has been updated to give a clearer focus on the outcomes of the TGA's evaluation process and the rationale on which a decision to accept or reject an application is made.
An Extract from the full Clinical Evaluation Report is now included as an Attachment to the AusPAR. The Extract contains the information that was previously included in the body of the AusPAR itself, which now includes only the clinical evaluator's summaries of pharmacokinetics, pharmacodynamics, efficacy and safety, as well as the first and second round benefit-risk assessments.
This change has not altered the overall content of the AusPAR.
- AusPARs: Questions & answers
An AusPAR summarises the steps in the evaluation process that led the TGA to approve or not approve a prescription medicine submission
- Australian Public Assessment Report (AusPAR) guidance
Information about the structure, and processes for the compilation, review and publishing of an AusPAR
|Active ingredient||Product name|
|25 February 2015|
|28 January 2015|
|Dapagliflozin (as propanediol monohydrate) / Metformin hydrochloride (HCl)||Xigduo XR 10/500, Xigduo XR 10/1000, Xigduo XR 5/1000|
- Browse AusPARs by active ingredient
The active ingredient is the component in the medicine that makes it work
- Browse AusPARs by product name
The product name is the registered trademark or unique name of the medicine appearing on the label
- Browse AusPARs by sponsor
The sponsor is the person or company responsible for applying to the TGA to have their medicine included in the Australian Register of Therapeutic Goods