Arosen 5 mg/10 mg tablete
| Name | Arosen 5 mg/10 mg tablete |
|---|---|
| Former Name | Rosuvastatin/Ezetimib Genericon 5 mg/10 mg tablete |
| Marketing Authorisation Number | HR-H-853800213 |
| Active Substance | rosuvastatinkalcij ezetimib |
| Composition | svaka tableta sadrži 5 mg rosuvastatina (u obliku rosuvastatinkalcija) i 10 mg ezetimiba |
| Pharmaceutical Form | tableta |
| Manufacturer | Genericon Pharma Gesellschaft m.b.H., Graz, Austrija Adamed Pharma S.A., Pabianice, Poljska |
| Marketing Authorisation Holder | Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, Austrija |
| Marketing Authorisation Date | 19.01.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/65 |
| Registration Number | 381-12-01/154-23-06 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C10BA06 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
