Roxampex 10 mg/5 mg/4 mg filmom obložene tablete
Name | Roxampex 10 mg/5 mg/4 mg filmom obložene tablete |
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Marketing Authorisation Number | HR-H-578545623 |
Active Substance | rosuvastatinkalcij amlodipinbesilat perindopril-tert-butilamin |
Composition | jedna filmom obložena tableta sadrži 10 mg rosuvastatina (u obliku rosuvastatinkalcija), 5 mg amlodipina (u obliku amlodipinbesilata) i 4 mg perindopril-tert-butilamina što odgovara 3,34 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-530-09/20-01/89 |
Registration Number | 381-12-01/70-21-13 |
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 |