Rosix-Am 10 mg/5 mg tvrde kapsule
Name | Rosix-Am 10 mg/5 mg tvrde kapsule |
---|---|
Former Name | Zahron Combi 10 mg/5 mg tvrde kapsule |
Marketing Authorisation Number | HR-H-275391137 |
Active Substance | rosuvastatinkalcij amlodipinbesilat |
Composition | svaka tvrda kapsula sadrži 10 mg rosuvastatina (u obliku rosuvastatinkalcija) i 5 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-530-09/16-01/237 |
Registration Number | 381-12-01/14-18-13 |
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 |