Arosen 20 mg/10 mg tablete
| Name | Arosen 20 mg/10 mg tablete |
|---|---|
| Former Name | Rosuvastatin/Ezetimib Genericon 20 mg/10 mg tablete |
| Marketing Authorisation Number | HR-H-870499295 |
| 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-870499295-01] 10 tableta u blisteru, u kutiji [HR-H-870499295-02] 14 tableta u blisteru, u kutiji [HR-H-870499295-03] 20 tableta u blisteru, u kutiji [HR-H-870499295-04] 28 tableta u blisteru, u kutiji [HR-H-870499295-05] 30 tableta u blisteru, u kutiji [HR-H-870499295-06] 50 tableta u blisteru, u kutiji [HR-H-870499295-07] 56 tableta u blisteru, u kutiji [HR-H-870499295-08] 60 tableta u blisteru, u kutiji [HR-H-870499295-09] 84 tablete u blisteru, u kutiji [HR-H-870499295-10] 90 tableta u blisteru, u kutiji [HR-H-870499295-11] 100 tableta u blisteru, u kutiji [HR-H-870499295-12] |
| 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-530-09/22-02/67 |
| Registration Number | 381-12-01/154-23-05 |
| 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 |
