Xofigo
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 | Xofigo |
|---|---|
| Active Substance | radijev[223Ra] diklorid |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product subject to restricted medical prescription |
| Distribution | Supply through pharmacies (community) |
| ATC Code | V10XX03 |
| 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 novim ograničenjima primjene lijeka Xofigo (radij-223 diklorid) zbog povećanog rizika od prijeloma i trenda povećanja smrtnosti | 17.08.2018 | Bayer AG |
| Pismo zdravstvenim radnicima o kontraindikaciji istodobne primjene lijeka Xofigo (radij-223 diklorid) s abirateronacetatom (Zytiga) i prednizonom/prednizolonom | 19.03.2018 | Bayer d.o.o. |
| Pismo zdravstvenim radnicima o povećanom riziku od smrtnih slučajeva i prijeloma u randomiziranom kliničkom ispitivanju lijeka Xofigo (radij-223 diklorid) u kombinaciji s abirateronacetatom i prednizonom/prednizolonom | 12.12.2017 | Bayer d.o.o. |
