Rosacol 5 mg filmom obložene tablete
| Name | Rosacol 5 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-693317326 |
| Active Substance | rosuvastatinkalcij |
| Composition | jedna filmom obložena tableta sadrži 5 mg rosuvastatina (u obliku rosuvastatinkalcija) |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 14 tableta u blisteru, u kutiji [HR-H-693317326-01] 15 tableta u blisteru, u kutiji [HR-H-693317326-02] 28 tableta u blisteru, u kutiji [HR-H-693317326-03] 30 tableta u blisteru, u kutiji [HR-H-693317326-04] 56 tableta u blisteru, u kutiji [HR-H-693317326-05] 60 tableta u blisteru, u kutiji [HR-H-693317326-06] 84 tableta u blisteru, u kutiji [HR-H-693317326-07] 90 tableta u blisteru, u kutiji [HR-H-693317326-08] 98 tableta u blisteru, u kutiji [HR-H-693317326-09] 28 tableta u bočici, u kutiji [HR-H-693317326-10] 30 tableta u bočici, u kutiji [HR-H-693317326-11] 56 tableta u bočici, u kutiji [HR-H-693317326-12] 60 tableta u bočici, u kutiji [HR-H-693317326-13] 84 tableta u bočici, u kutiji [HR-H-693317326-14] 90 tableta u bočici, u kutiji [HR-H-693317326-15] |
| Manufacturer | Generics [UK] Limited, Hertfordshire, Ujedinjeno Kraljevstvo McDermott Laboratories Limited, t/a Gerard Laboratories, Dublin 13, Irska Mylan Hungary Kft, Komárom, Mađarska |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Irska |
| Marketing Authorisation Date | 24.11.2021 |
| MA Period of Validity | 30.11.2023 |
| Classification Number | UP/I-530-09/18-01/78 |
| Registration Number | 381-12-01/70-21-24 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C10AA07 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
