Omologazioni in worksharing del gruppo Access Consortium

Prodotti omologati da Swissmedic nell’ambito della New Active Substance Work Sharing Initiative (NASWSI) dell’Access Consortium:

Medicamento Principio attivo Autorità partner Link
Xofluza® Baloxavir Marboxil Australia’s Therapeutic Goods Administration (TGA), Health Canada Swissmedic omologa per la prima volta una nuova sostanza attiva (NAS) nell’ambito del Consorzio ACSS
Kesimpta® Ofatumumab Australia’s Therapeutic Goods Administration (TGA) , Health Canada, Health Sciences Authority (HSA) Singapore
Swissmedic ha omologato un nuovo medicamento nell’ambito dell’Access Consortium
VeraSeal® Fibrinogeno e Thrombina 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) Collaborazione internazionale nel settore degli agenti terapeutici
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  

Prodotti omologati da Swissmedic nell’ambito della Generic Medicines Work Sharing Initiative (GMWSI) dell’Access Consortium:

Medicamento Principio attivo Autorità partner  Link
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  

Prodotti omologati da Swissmedic nell’ambito della Biosimilar Medicines Work Sharing Initiative (BSWSI) dell’Access Consortium:

Medicamento Principio attivo Autorità partner Link
Obodence® Denosumab Medicines and Healthcare Products Regulatory Agency (MHRA)  

Ultima modifica 28.01.2026

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