Rybelsus
The medicinal product has been authorised by the European Commission (EC) via centralised procedure in all EU Member States, based on the European Medicines Agency (EMA) experts' opinion.
| Name | Rybelsus |
|---|---|
| Active Substance | semaglutid |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| ATC Code | A10BJ06 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| Summary of product characteristics (SmPC), labelling and package leaflet (PL) | download |
| Link to the European Medicines Agency's (EMA) product information | download |
| Link to the European Commission's (EC) decisions | download |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku od medikacijske pogreške kod primjene lijeka Rybelsus (oralni semaglutid) zbog uvođenja nove formulacije s povećanom bioraspoloživošću | 30.04.2026 | Novo Nordisk Hrvatska d.o.o. |
