Access Consortium Work Sharing Zulassungen von Swissmedic

Arzneimittel, welche von Swissmedic im Rahmen der Access Consortium New Active Substance Work Sharing Initiative (NASWSI) zugelassen wurden:

Arzneimittel Wirkstoff Beteiligte Behörden Weiterführende Links
Xofluza® Baloxavir Marboxil Australia’s Therapeutic Goods Administration (TGA), Health Canada Swissmedic lässt erstmals eine neue aktive Substanz (NAS) im Rahmen des ACSS Consortiums zu
Kesimpta® Ofatumumab Australia’s Therapeutic Goods Administration (TGA), Health Canada, Health Sciences Authority (HSA) Singapore Swissmedic lässt erneut ein Arzneimittel im Rahmen des Access Consortiums zu
VeraSeal® Fibrinogen und 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) Internationale Zusammenarbeit im Heilmittelbereich
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  
Andembry® Garadacimab Australia’s Therapeutic Goods Administration (TGA),  Health Canada, Medicines and Healthcare Products Regulatory Agency (MHRA)  
Rystiggo® Rozanolixizumab Australia’s Therapeutic Goods Administration (TGA),  Health Canada  
Vyloy® Zolbetuximab Australia’s Therapeutic Goods Administration (TGA), Health Sciences Authority (HSA) Singapore  
Hympavzi® Marstacimab Australia’s Therapeutic Goods Administration (TGA), Health Sciences Authority (HSA) Singapore  
Nemluvio® Nemolizumab Australia’s Therapeutic Goods Administration (TGA),  Health Sciences Authority (HSA) Singapore, Medicines and Healthcare Products Regulatory Agency (MHRA)  

Arzneimittel, welche von Swissmedic im Rahmen der Access Consortium Generic Medicines Work Sharing Initiative (GMWSI) zugelassen wurden:

Arzneimittel Wirkstoff Beteiligte Behörden Weiterführende 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)  

Arzneimittel, welche von Swissmedic im Rahmen der Access Consortium Biosimilar Medicines Work Sharing Initiative (BSWSI) zugelassen wurden:

Arzneimittel Wirkstoff Beteiligte Behörden Weiterführende Links
Obodence® Denosumab Medicines and Healthcare Products Regulatory Agency (MHRA)  

Letzte Änderung 05.05.2025

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