Ezetimib/atorvastatin Sandoz 10 mg/80 mg filmom obložene tablete
| Name | Ezetimib/atorvastatin Sandoz 10 mg/80 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-898676220 |
| Active Substance | ezetimib atorvastatinkalcij trihidrat |
| Composition | jedna filmom obložena tableta sadrži 10 mg ezetimiba i 80 mg atorvastatina u obliku atorvastatinkalcij trihidrat |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija
Elpen Pharmaceutical Co.Inc. (SA), Pikermi, Attica, Grčka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 24.04.2024 |
| MA Period of Validity | 24.04.2029 |
| Classification Number | UP/I-530-09/22-01/184 |
| Registration Number | 381-12-01/70-24-07 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | C10BA05 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
