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 | 02.07.2020 |
| MA Period of Validity | 02.07.2025 |
| Classification Number | UP/I-530-09/18-01/153 |
| Registration Number | 381-12-01/154-20-04 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C10BX05 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
