Roxampex 20 mg/5 mg/8 mg filmom obložene tablete
| Name | Roxampex 20 mg/5 mg/8 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-159080548 |
| Active Substance | rosuvastatinkalcij amlodipinbesilat perindopril-tert-butilamin |
| Composition | jedna filmom obložena tableta sadrži 20 mg rosuvastatina (u obliku rosuvastatinkalcija), 5 mg amlodipina (u obliku amlodipinbesilata) i 8 mg perindopril-tert-butilamina što odgovara 6,68 mg perindoprila |
| 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 | 10.06.2021 |
| MA Period of Validity | 06.04.2026 |
| Classification Number | UP/I-530-09/20-01/92 |
| Registration Number | 381-12-01/70-21-08 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C10BX14 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
