Applications that have successfully received market approval through the Access Consortium “New Active Substance Work Sharing Initiative” (NASWSI) in Switzerland:
| Medicinal product | Active substance | Partner agencies involved | Links |
|---|---|---|---|
| Xofluza® | Baloxavir Marboxil | Australia’s Therapeutic Goods Administration (TGA), Health Canada | Swissmedic authorises a new active substance (NAS) under the ACSS Consortium initiative for the first time |
| Kesimpta® | Ofatumumab | TGA Australien, Health Canada, Health Sciences Authority (HSA) Singapore |
Swissmedic authorises another medicinal product under the Access Consortium initiative |
| VeraSeal® | Fibrinogen and Thrombin | Australia’s Therapeutic Goods Administration (TGA), Health Canada | |
| Verquvo® | Vericiguat | Australia’s Therapeutic Goods Administration (TGA), Health Sciences Authority (HSA) Singapore |
|
| Kerendia® | Finerenone | Health Sciences Authority (HSA) Singapore, Australia’s Therapeutic Goods Administration (TGA) | |
| Nexviadyme® | Avalglucosidase alfa | Health Canada, Australia’s Therapeutic Goods Administration (TGA) | |
| Cibinqo® | Abrocitinib | Health Sciences Authority (HSA) Singapore | |
| Vabysmo® | Faricimab | Australia’s Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HSA) Singapore, Medicines and Healthcare Products Regulatory Agency (MHRA) | International cooperation on therapeutic products |
| Scemblix® | Asciminib | Australia’s Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HSA) Singapore, Medicines and Healthcare Products Regulatory Agency (MHRA) | |
| Kapruvia® | Difelikefalin | Australia’s Therapeutic Goods Administration (TGA), Health Canada | |
| Mounjaro® | Tirzepatid | Australia’s Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HAS) Singapore | |
| Tavneos® | Avacopan | Health Canada | |
| Vafseo® | Vadadustat | Australia’s Therapeutic Goods Administration (TGA), MHRA | |
| Alhemo® | Concizumab | Australia’s Therapeutic Goods Administration (TGA), Health Canada |
Applications that have successfully received market approval through the Access Consortium “Generic Medicines Work Sharing Initiative” (GMWSI) in Switzerland:
| Generic Medicines | Active substance | Partner agencies involved | Links |
|---|---|---|---|
| Everolimus Teva® | Everolimus | Australia’s Therapeutic Goods Administration (TGA), Health Canada | |
| Dabigatran Sandoz® | Dabigatran | Australia’s Therapeutic Goods Administration (TGA) |
Last modification 14.12.2023