Rosix Combi 20 mg/10 mg tablete
| Name | Rosix Combi 20 mg/10 mg tablete |
|---|---|
| Former Name | Ezehron Duo 20 mg/10 mg tablete |
| Marketing Authorisation Number | HR-H-791429746 |
| Active Substance | rosuvastatinkalcij ezetimib |
| Composition | svaka tableta sadrži 20 mg rosuvastatina (u obliku rosuvastatinkalcija) i 10 mg ezetimiba |
| Pharmaceutical Form | tableta |
| Packaging [MA Number for Packaging] | 7 tableta u blisteru, u kutiji [HR-H-791429746-01] 10 tableta u blisteru, u kutiji [HR-H-791429746-02] 14 tableta u blisteru, u kutiji [HR-H-791429746-03] 28 tableta u blisteru, u kutiji [HR-H-791429746-04] 30 tableta u blisteru, u kutiji [HR-H-791429746-05] 56 tableta u blisteru, u kutiji [HR-H-791429746-06] 60 tableta u blisteru, u kutiji [HR-H-791429746-07] 84 tablete u blisteru, u kutiji [HR-H-791429746-08] 90 tableta u blisteru, u kutiji [HR-H-791429746-09] 98 tableta u blisteru, u kutiji [HR-H-791429746-10] 100 tableta u blisteru, u kutiji [HR-H-791429746-11] |
| Manufacturer | Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
| Marketing Authorisation Holder | Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
| Marketing Authorisation Date | 24.08.2018 |
| MA Period of Validity | 10.05.2023 |
| Classification Number | UP/I-530-09/16-01/263 |
| Registration Number | 381-12-01/14-18-05 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C10BA06 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
