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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 10

Enter a product name, active ingredient or sponsor

Decision: Approved

Date of entry onto ARTG: 1 Nov 2019

Published: 8 Nov 2019

Active ingredient
Siponimod

Sponsor
Novartis Pharmaceuticals Australia Pty Ltd

Decision: Approved

Date of entry onto ARTG: 21 Oct 2019

Published: 28 Oct 2019

Active ingredient
Polatuzumab vedotin

Sponsor
Roche Products Pty Limited

Decision: Approved

Date of entry onto ARTG: 17 Oct 2019

Published: 25 Oct 2019

Active ingredient
Ravulizumab rch

Sponsor
Alexion Pharmaceuticals Australasia Pty Ltd

Decision: Approved

Date of entry onto ARTG: 1 Oct 2019

Published: 10 Oct 2019

Active ingredient
Inactivated quadrivalent influenza vaccine (surface antigen)

Sponsor
Seqirus Pty Ltd (Australia)

Decision: Approved

Date of entry onto ARTG: 1 Oct 2019

Published: 9 Oct 2019

Active ingredient
Cenegermin (rbe)

Sponsor
JACE Pharma Pty Ltd

Decision: Approved

Date of entry onto ARTG: 20 Sep 2019

Published: 27 Sep 2019

Active ingredient
Fremanezumab

Sponsor
Teva Pharma Australia Pty Ltd

Decision: Approved

Date of entry onto ARTG: 13 Sep 2019

Published: 24 Sep 2019

Active ingredient
Stiripentol

Sponsor
Emerge Health Pty Ltd

Decision: Approved

Date of entry onto ARTG: 16 Sep 2019

Published: 24 Sep 2019

Active ingredient
Methoxsalen

Sponsor
Terumo BCT Australia Pty Ltd

Decision: Approved

Date of entry onto ARTG: 6 Sep 2019

Published: 17 Sep 2019

Active ingredient
Pegfilgrastim

Sponsor
Sandoz Pty Ltd

Decision: Approved

Date of entry onto ARTG: 4 Sep 2019

Published: 10 Sep 2019

Active ingredient
Nonacog beta pegol

Sponsor
Novo Nordisk Pharmaceuticals Pty Ltd