Roxiper 10 mg/8 mg/2,5 mg filmom obložene tablete
| Name | Roxiper 10 mg/8 mg/2,5 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-638321830 |
| Active Substance | rosuvastatinkalcij perindopril-tert-butilamin indapamid |
| Composition | jedna filmom obložena tableta sadrži 10 mg rosuvastatina (u obliku rosuvastatinkalcija), 8 mg perindopril-tert-butilamina što odgovara 6,68 mg perindoprila i 2,5 mg indapamida |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Krka d.d. Novo mesto, Novo Mesto, Slovenija |
| Marketing Authorisation Holder | Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
| Marketing Authorisation Date | 28.02.2025 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/24-02/78 |
| Registration Number | 381-12-01/70-25-02 |
| 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 | C10BX13 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
