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Australian prescription medicine decision summaries

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.

The Australian Prescription Medicine Decision Summary provides a short overview of the TGA's evaluation process leading to the registration of a new prescription medicine on the Australian Register of Therapeutic Goods (ARTG).

More in-depth information about the evaluation will be available in the Australian Public Assessment Report (AusPAR) for a particular prescription medicine, which can be found on the AusPAR search page once published.

Australian prescription medicine decision summaries

Displaying 1 - 10 of 32

Enter a product name, active ingredient or sponsor

Decision: Approved

Date of entry onto ARTG: 15 May 2020

Published: 25 May 2020

Active ingredient
Entrectinib

Sponsor
Roche Products Pty Limited

Decision: Approved

Date of entry onto ARTG: 6 May 2020

Published: 14 May 2020

Active ingredient
Isatuximab

Sponsor
Sanofi-Aventis Pty Ltd

Decision: Approved

Date of entry onto ARTG: 20 Apr 2020

Published: 29 Apr 2020

Active ingredient
Vonicog alfa

Sponsor
Shire Australia Pty Limited

Decision: Approved

Date of entry onto ARTG: 9 Apr 2020

Published: 17 Apr 2020

Active ingredient
Gemtuzumab ozogamicin

Sponsor
Pfizer Australia Pty Ltd

Decision: Approved

Date of entry onto ARTG: 2 Apr 2020

Published: 11 Apr 2020

Active ingredient
Gilteritinib (as fumarate)

Sponsor
Astellas Pharma Australia Pty Ltd

Decision: Approved

Date of entry onto ARTG: 2 Apr 2020

Published: 11 Apr 2020

Active ingredient
Dinutuximab beta

Sponsor
Emerge Health Pty Ltd

Decision: Approved

Date of entry onto ARTG: 20 Mar 2020

Published: 27 Mar 2020

Active ingredient
Alpelisib

Sponsor
Novartis Pharmaceuticals Australia Pty Ltd

Decision: Approved

Date of entry onto ARTG: 16 Mar 2020

Published: 23 Mar 2020

Active ingredient
Tafamidis and tafamidis meglumine

Sponsor
Pfizer Australia Pty Ltd

Decision: Approved

Date of entry onto ARTG: 26 Feb 2020

Published: 4 Mar 2020

Active ingredient
Darolutamide

Sponsor
Bayer Australia Limited

Decision: Approved

Date of entry onto ARTG: 21 Feb 2020

Published: 2 Mar 2020

Active ingredient
Baloxavir marboxil

Sponsor
Roche Products Pty Limited

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