Autorisations qui ont été délivrées par Swissmedic dans le cadre de l’initiative de partage des tâches pour les nouveaux principes actifs NASWSI (New Active Substance Work Sharing Initiative) du Consortium Access:
Autorisations de mise sur le marché délivrées dans le cadre d'un partage du travail au niveau de l'Access Consortium
| Médicament | Princip actif | Autorités partenaires concernées | Liens supplémentaires |
|---|---|---|---|
| Xofluza® | Baloxavir Marboxil | Australia’s Therapeutic Goods Administration (TGA), Health Canada | Swissmedic autorise pour la première fois une nouvelle substance active (NAS) dans le cadre du Consortium ACSS |
| Kesimpta® | Ofatumumab | Australia’s Therapeutic Goods Administration (TGA) , Health Canada, Health Sciences Authority (HSA) Singapore |
Swissmedic autorise à nouveau un médicament dans le cadre du Consortium Access |
| VeraSeal® | Fibrinogène et Thrombine | 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) | Coopération internationale dans le domaine des produits thérapeutiques |
| 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 |
Autorisations qui ont été délivrées par Swissmedic dans le cadre de l’initiative de partage des tâches pour les "Generic Medicines Work Sharing Initiative" du Consortium Access:
| Médicament | Princip actif | Autorités partenaires concernées | Liens supplémentaires |
|---|---|---|---|
| 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) |
Dernière modification 02.10.2024