Roxiper 10 mg/8 mg/2,5 mg filmom obložene tablete
Name | Roxiper 10 mg/8 mg/2,5 mg filmom obložene tablete |
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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 | 22.04.2020 |
MA Period of Validity | 28.02.2025 |
Classification Number | UP/I-530-09/18-01/232 |
Registration Number | 381-12-01/154-20-09 |
Prescription | na recept |
Type of prescription | ponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | C10BX13 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |