Rosix-Am 20 mg/10 mg tvrde kapsule
| Name | Rosix-Am 20 mg/10 mg tvrde kapsule |
|---|---|
| Former Name | Zahron Combi 20 mg/10 mg tvrde kapsule |
| Marketing Authorisation Number | HR-H-542074590 |
| Active Substance | rosuvastatinkalcij amlodipinbesilat |
| Composition | jedna tvrda kapsula sadrži 20 mg rosuvastatina (u obliku rosuvastatinkalcija) i 10 mg amlodipina (u obliku amlodipinbesilata) |
| 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 | 22.08.2018 |
| MA Period of Validity | 22.05.2023 |
| Classification Number | UP/I-530-09/16-01/240 |
| Registration Number | 381-12-01/14-18-10 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C10BX09 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
