Rosix Duo 5 mg/100 mg tvrde kapsule
| Name | Rosix Duo 5 mg/100 mg tvrde kapsule |
|---|---|
| Marketing Authorisation Number | HR-H-076410504 |
| Active Substance | rosuvastatinkalcij acetilsalicilatna kiselina |
| Composition | jedna tvrda kapsula sadrži 5 mg rosuvastatina (u obliku rosuvastatin kalcija) i 100 mg acetilsalicilatne kiseline |
| Pharmaceutical Form | kapsula, tvrda |
| Manufacturer | Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
| Marketing Authorisation Holder | Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
| Marketing Authorisation Date | 28.10.2024 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/24-02/60 |
| Registration Number | 381-12-01/171-24-06 |
| 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 | C10BX05 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
