Coupet Combi 20 mg/10 mg filmom obložene tablete
| Name | Coupet Combi 20 mg/10 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-528530440 |
| Active Substance | rosuvastatinkalcij ezetimib |
| Composition | svaka filmom obložena tableta sadrži 20 mg rosuvastatina u obliku rosuvastatinkalcija i 10 mg ezetimiba |
| Pharmaceutical Form | Filmom obložena tableta |
| Packaging [MA Number for Packaging] | 10 tableta u blisteru, u kutiji [HR-H-528530440-01] 30 tableta u blisteru, u kutiji [HR-H-528530440-02] 90 tableta u blisteru, u kutiji [HR-H-528530440-03] 100 tableta u blisteru, u kutiji [HR-H-528530440-04] 10 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-528530440-05] 30 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-528530440-06] 90 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-528530440-07] 100 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-528530440-08] 28 tableta u blisteru, u kutiji [HR-H-528530440-09] 28 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-528530440-10] |
| Manufacturer | Elpen Pharmaceutical Co.Inc. (SA), Pikermi, Attica, Grčka Lek Pharmaceuticals d.d., Ljubljana, Slovenija Elpen Pharmaceutical Co. Inc., Keratea, Attiki, Grčka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 29.06.2022 |
| MA Period of Validity | 29.06.2027 |
| Classification Number | UP/I-530-09/20-01/240 |
| Registration Number | 381-12-01/154-22-07 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | C10BA06 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
