New Active Substance and Generic Medicine approvals
Approvals as of 31 December 2024:
We will periodically update the below lists with products approved through Access collaborative assessment procedures.
New Active Substances
Access Pathway | Trade Name | Active Substance | Year of Approval | Participating Agencies | Therapeutic Area |
Standard | Vyndaqel | Tafamidis | 2020 | TGA/HSA | Other Nervous System Drugs |
Standard | Sarclisa | Isatuximab | 2021 | TGA/HC | Antineoplastic Agents |
Standard | Kesimpta | Ofatumumab | 2021 | TGA/HC/HSA/SMC | Immunosuppressants |
Standard | VeraSeal fibrin sealant | Human fibrinogen, human thrombin | 2021 | TGA/HC/SMC | Antihemorrhagics |
Standard | Verquvo | Vericiguat | 2021 | TGA/HSA/SMC | Cardiac Therapy |
Standard | Leqvio | Inclisiran | 2021 | TGA/HC/HSA | Lipid Modifying Agents |
Standard | Nexviadyme | Avalglucosidase alfa | 2021 | TGA/HSA/SMC | Other Alimentary Tract and Metabolism Products |
Standard | Cibinqo | Abrocitinib | 2022 | SMCAHRA | Other Dermatological Preparations |
Standard | Kerendia | Finerenone | 2022 | TGA/HSA | Diuretics |
Standard | Somatrogon | human growth hormone | 2021 | TGA/HC | Pituitary and Hypothalamic Hormones and Analogues |
Standard | Vabysmo | faricimab | 2022 | TGA/HC/SMC/HSA/MHRA | Ophthalmologicals |
Standard | Scemblix | asciminib | 2022 | TGA/HC/SMC/HSA/MHRA | Antineoplastic Agents |
Standard | Tavneos | avacopan | 2022 | SMC/HC | Immunosuppressants |
Standard | Korsuva/Kapruvia | difelikefalin | 2022 | TGA/HC/SMC/HSA | All Other Therapeutic Products |
Standard | Mounjaro | Tirzepatide | 2022 | TGA/HC/SMC/HSA | Drugs used in Diabetes |
Standard | Vafseo | vadadustat | 2023 | TGA/SMC/MHRA | Antianemic Preparations |
Standard | Omvoh | mirikizumab | 2023 | TGA, SMC | Immunosuppressants |
Priority | Alhemo | concizumab | 2023 | TGA/HC/SMC | Antihemorrhagics |
Standard | Veoza | Fezolinetant | 2023 | TGA/SMC | Other Gynecologicals |
Standard | Awiqli | Insulin icodec | 2024 | TGA/HC/SMC | Drugs used in Diabetes |
Standard | Velsipity | Etrasimod L-arginine | 2024 | SMC/HSA | Immunosuppressants |
Priority | WINREVAIR | Sotatercept | 2024 | TGA/HC/HSA/SMC | Antihypertensives |
Standard | Fruzaqla | Fruquintinib | 2024 | TGA/HC/SMC/HSA/MHRA | Antineoplastic Agents |
Standard | Hympavzi | Marstacimab | 2024 | TGA/HSA/SMC | Antithrombotic Agents |
Generic Medicines
Content under development