Co-Roswera 5 mg/10 mg filmom obložene tablete
| Name | Co-Roswera 5 mg/10 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-578445810 |
| Active Substance | rosuvastatinkalcij ezetimib |
| Composition | jedna filmom obložena tableta sadrži 5 mg rosuvastatina (u obliku rosuvastatinkalcija) i 10 mg ezetimiba |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Krka d.d. Novo mesto, Novo Mesto, Slovenija
TAD Pharma Gmbh, Cuxhaven, Njemačka |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 25.09.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/23-02/11 |
| Registration Number | 381-12-01/286-24-07 |
| 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 | C10BA06 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
