Xgeva
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 | Xgeva |
|---|---|
| Active Substance | denosumab |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| ATC Code | M05BX04 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| 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 |
| Educational materials for patients / caregivers |
Kartica za bolesnika |
Packaging
Direct Healthcare Professional Communication
| Name | Date | Download |
|---|---|---|
| Pismo zdravstvenim radnicima o riziku nastanka nove primarne maligne bolesti uz primjenu lijeka XGEVA (denosumab) | 17.05.2018 | Amgen Europe B.V. |
| Pismo zdravstvenim radnicima o riziku od osteonekroze čeljusti uz primjenu denosumaba (XGEVA) | 30.10.2015 | Amgen d.o.o. |
