Australian Public Assessment Reports for prescription medicines (AusPARs)

~w2018-11-22

An AusPAR provides information about the evaluation of a prescription medicine and the considerations that led the Therapeutic Goods Administration (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 version of the Product Information for that prescription medicine which was approved with the submission which the AusPAR describes. Product Information may have been updated since the AusPAR was prepared. For the current Product Information for a medicine please see: Product Information (PI).

Recently, TGA published AusPAR’s for the following active ingredients:

Date

Active Ingredient

Product Name

21 Nov

Elvitegravir/ cobicistat / emtricitabine / tenofovir alafenamide (as fumarate)

Genvoya

21 Nov

Bezlotoxumab

Zinplava

15 Nov

Brexpiprazole

Rexulti

13 Nov

Alirocumab

Praluent

12 Nov

Fosfomycintrometamol

Monurol

8 Nov

Pegaspargase

Oncaspar

24 Oct

Leuprorelin

Eligard

~sTGA 21 November 2018

http://www.tga.gov.au/