Co-Roswera 15 mg/10 mg filmom obložene tablete
| Name | Co-Roswera 15 mg/10 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-319752844 |
| Active Substance | rosuvastatinkalcij ezetimib |
| Composition | jedna filmom obložena tableta sadrži 15 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-530-09/23-02/13 |
| Registration Number | 381-12-01/286-24-06 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C10BA06 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |