Refidoro 5 mg/10 mg filmom obložene tablete
| Name | Refidoro 5 mg/10 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-135500128 |
| Active Substance | rosuvastatinkalcij ezetimib |
| Composition | svaka filmom obložena tableta sadrži 5 mg rosuvastatina u obliku rosuvastatinkalcija i 10 mg ezetimiba |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Alkaloid - INT d.o.o., Ljubljana - Črnuče, Slovenija |
| Marketing Authorisation Holder | Alkaloid - INT d.o.o., Šlandrova ulica 4, Ljubljana - Črnuče, Slovenija |
| Marketing Authorisation Date | 14.12.2022 |
| MA Period of Validity | 14.12.2027 |
| Classification Number | UP/I-530-09/21-01/220 |
| Registration Number | 381-12-01/154-22-07 |
| 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 |
| Summary of risk management plan | download |
