Who is the medicines regulator in Australia?

TGA is the medicines regulator for Australia. They evaluate, license, and inspect medicines in scope. Separately, PBAC runs the health technology assessment process for reimbursement decisions.

How many drugs are approved in Australia?

Drug Landscape tracks 500 drug approvals in Australia. Each entry links back to the manufacturer and full regulatory record.

PBAC is the health technology assessment body for Australia. It reviews clinical and cost-effectiveness evidence for new medicines and issues guidance on whether they should be reimbursed by the public payer.

How much do prescription medicines cost in Australia?

Drug Landscape has 5 drug pricing records for Australia, sourced from public reimbursement lists and manufacturer disclosures. Reimbursement status and annual cost are flagged where available.

Australia — Pharmaceutical Approvals & Pricing

TGA PBAC · 500 approvals · 5 pricing records

TGA is the medicines regulator for Australia. PBAC runs the health technology assessment process. This page lists every drug we have a tracked approval or pricing record for in Australia.

Approvals

Locametz · Univ Ca Los Angeles · Fri Dec 09 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Mounjaro · Eli Lilly · Thu Sep 15 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Metabolic
Nurtec Odt · Pfizer · Mon Apr 25 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Neuroscience
Oxbryta · Global Blood Theraps · Mon Feb 14 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Hematology
Paxlovid (Copackaged) · Pfizer · Fri Jan 28 2022 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Infectious Disease
IMDEVIMAB · Regeneron Pharmaceuticals, Inc. · Fri Nov 12 2021 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Infectious Disease
Hu38Sb19 · Sanofi · Sat May 30 2020 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Talzenna · Pfizer Inc. · Wed Aug 07 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Macrilen · Aeterna Zentaris · Fri Jan 11 2019 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Other
Ozempic · Novo Nordisk · Thu Feb 08 2018 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Metabolic
Besponsa · Pfizer Inc. · Thu Jul 13 2017 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Besponsa · Pfizer · Thu Jun 29 2017 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Xeljanz · Pfizer · Wed Mar 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time) · approved
Xeljanz · Pfizer · Wed Mar 22 2017 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Immunology
Ibrance · Pfizer · Wed Nov 09 2016 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Keytruda · Merck & Co. · Fri Jul 17 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Cosentyx · Novartis · Wed Jan 14 2015 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Immunology
Vyndaqel · Foldrx Pharms · Wed Nov 16 2011 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Neuroscience
Neupogen · Amgen · Mon Sep 15 2008 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Sutent · Pfizer · Wed Jul 19 2006 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Omnitrope · Serono · Wed Apr 12 2006 00:00:00 GMT+0000 (Coordinated Universal Time) · approved
Bevacizumab · Roche · Thu Dec 01 2005 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Zevalin · Spectrum Pharms · Fri Jan 16 2004 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Herceptin · Roche · Mon Aug 28 2000 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Remicade · Johnson & Johnson · Fri Aug 13 1999 00:00:00 GMT+0000 (Coordinated Universal Time) · approved · Oncology
Pradaxa · approved
Xerava · Tetraphase Pharms · approved · Infectious Disease
Skyclarys · Biogen Us · approved · Other
Elucirem · Guerbet · approved · Other
Tecartus · approved
Yescarta · approved
Exdensur · Glaxosmithkline Llc · approved · Respiratory
Vimpat · UCB · approved · Neuroscience
Alkindi · Generic (originally Merck/Upjohn) · approved · Oncology
Insuman · approved
Imatinib Teva · approved
Entyvio · Takeda · approved · Gastroenterology
Vyloy · Astellas · approved · Oncology
Nivestim · approved
Nexium Control · AstraZeneca · approved · Immunology
Jeraygo · Idorsia · approved · Metabolic
Zyprexa · Eli Lilly · approved · Neuroscience
Sycrest · Hisamitsu · approved · Neuroscience
Tadalafil Mylan · Eli Lilly · approved · Urology
Exelon · Novartis · approved · Neuroscience
Tepadina · approved
Inluriyo · Eli Lilly And Co · approved · Oncology
Piasky · Genentech Inc · approved · Immunology
Datroway · approved
Tepkinly · Genmab Us, Inc. · approved · Oncology
Cibinqo · approved
Kesimpta · Novartis · approved · Immunology
Clopidogrel Zentiva (previously Clopidogrel Winthrop) · Generic (originally Sanofi/BMS) · approved · Metabolic
Vanflyta · Daiichi Sankyo Inc · approved · Oncology
Leqembi · Eisai · approved · Immunology
Arixtra · approved
Heplisav B · Central Hospital, Nancy, France · approved · Immunology / Infectious Disease
Pomalidomide Teva · approved
Zegalogue · Zealand Pharma · approved · Metabolic
Tevimbra · Beigene · approved · Oncology
Austedo · Teva · approved · Metabolic
Nevanac · Harrow Health · approved · Metabolic
Abraxane · approved
Odomzo · approved
Daptomycin Hospira · Baxter · approved · Metabolic
Imaavy · Janssen Biotech · approved · Immunology
Tobi Podhaler · Novartis · approved · Infectious Disease
Carbaglu · Recordati · approved · Gastroenterology
Loargys · approved
Anzupgo · Japan Tobacco · approved · Immunology
Kimmtrak · approved
Dacogen · Sun Pharma · approved · Oncology
Abecma · Bristol-Myers Squibb · approved · Oncology
Xermelo · approved
Filspari · approved
Lyfnua · approved
Adynovi · Spanish Society of Thrombosis and Haemostasis · approved
Jivi · approved
Brinsupri · Insmed Inc · approved · Respiratory
Enhertu · approved
Adempas · Bayer · approved · Metabolic
Mekinist · approved
Tecovirimat SIGA · approved
Rezdiffra · approved
Kymriah · Novartis Pharmaceuticals Corporation · approved · Oncology
Pegasys · Hoffman-La Roche · approved · Infectious Disease
Beyonttra · Bridgebio Pharma · approved · Cardiovascular
Mektovi · Pfizer · approved · Oncology
Braftovi · Pfizer · approved · Oncology
Ivemend · approved · Oncology
Zurzuvae · Biogen · approved · Neuroscience
Votrient · approved
Multaq · Sanofi · approved · Cardiovascular
Lemtrada · Sanofi · approved · Oncology
Emend · Merck & Co. · approved · Oncology
Tygacil · Fresenius Kabi · approved · Infectious Disease
Aqumeldi · Azurity · approved · Cardiovascular
Diacomit · approved
Duloxetine Viatris (previously Duloxetine Mylan) · Eli Lilly and Company · approved · Metabolic
Arikayce liposomal · Bristol-Myers Squibb · approved · Immunology

Pricing

Drug	Price	Per
Prevnar 20	AUD 78.00	year
Prevnar 20	AUD 78.00	year
Prevnar 20	AUD 78.00	year
Prevnar 20	AUD 78.00	year
Prevnar 20	AUD 78.00	year

Other countries

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