Access Consortium work-sharing authorisations

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 (HSA) Singapore  
Tavneos® Avacopan Health Canada  
Vafseo® Vadadustat Australia’s Therapeutic Goods Administration (TGA), Medicines and Healthcare Products Regulatory Agency (MHRA)  
Alhemo® Concizumab Australia’s Therapeutic Goods Administration (TGA), Health Canada  
Omvoh® Mirikizumab Australia’s Therapeutic Goods Administration (TGA)  
Veoza® Fezolinetant Australia’s Therapeutic Goods Administration (TGA)  
Awiqli® Insulin icodec Health Canada, Australia’s Therapeutic Goods Administration (TGA)  
Fruzaqla® Fruquintinib Australia’s Therapeutic Goods Administration (TGA),  Health Canada, Health Sciences Authority (HSA) Singapore, Medicines and Healthcare Products Regulatory Agency (MHRA)  
Velsipity® Etrasimod Health Sciences Authority (HSA) Singapore  
Winrevair® Sotatercept Australia’s Therapeutic Goods Administration (TGA),  Health Canada, Health Sciences Authority (HSA) Singapore  

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)  
Agilus® Dantrolen Medicines and Healthcare Products Regulatory Agency (MHRA)  
Enzalutamid Sandoz® Enzalutamid Medicines and Healthcare Products Regulatory Agency (MHRA)  

Last modification 02.10.2024

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