Rosix Duo 5 mg/100 mg tvrde kapsule
Name | Rosix Duo 5 mg/100 mg tvrde kapsule |
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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 |