Sortis Plus 10 mg/80 mg filmom obložene tablete
| Name | Sortis Plus 10 mg/80 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-410205077 |
| Active Substance | ezetimib atorvastatinkalcij trihidrat |
| Composition | svaka filmom obložena tableta sadrži 10 mg ezetimiba i 80 mg atorvastatina (u obliku atorvastatinkalcij trihidrata) |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Delorbis Pharmaceuticals Ltd, Lefkosia, Ergates, Cipar |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 24.01.2024 |
| MA Period of Validity | 24.01.2029 |
| Classification Number | UP/I-530-09/23-01/117 |
| Registration Number | 381-12-01/286-24-06 |
| 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 | C10BA05 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
