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. New AusPARs may be provided to reflect changes to indications or major variations to a prescription medicine subject to evaluation by the TGA.
The AusPAR and the Product Information (PI) approved with the submission are published as one document. Product Information may have been updated since the AusPAR was prepared.
For the current Product Information for a medicine, see Product Information.
Search Australian Public Assessment Reports for prescription medicines (AusPARs)
More information on AusPARs
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GuidanceGuidance on the information that we include in AusPARS for prescription medicines and when we publish them.
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PageThe Australian prescription medicine decision summary (AusPMDS) provides a brief overview of the TGA’s assessment and decision to approve or not approve registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).
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GuidanceGuidance for the deletion of commercially confidential and personal information in an Australian Public Assessment Report (AusPAR).
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PageWe provide transparency of the prescription medicines registration process via the online publication of Australian Public Assessment Reports (AusPARs). Explore questions and answers about AusPARs.
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