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)  
Datroway® Datopotamab Australia’s Therapeutic Goods Administration (TGA), Health Sciences Authority (HSA) Singapore  
Lynkuet® Elinzanetant Australia’s Therapeutic Goods Administration (TGA),  Health Canada, Medicines and Healthcare Products Regulatory Agency (MHRA)  
Ekterly® Sebetralstat Australia’s Therapeutic Goods Administration (TGA), Health Sciences Authority (HSA) Singapore, Medicines and Healthcare Products Regulatory Agency (MHRA)  
Imaavy® Nipocalimab Health Canada  
Enflonsia® Clesrovimab Australia’s Therapeutic Goods Administration (TGA),  Health Canada, Medicines and Health Sciences Authority (HSA) Singapore  
Kisunla® Donanemab Australia’s Therapeutic Goods Administration (TGA),  Medicines and Health Sciences Authority (HSA) Singapore  

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)  
Tofacitinib Sandoz® Tofacitinib Health Canada  

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 28.01.2026

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