Ezetimib/atorvastatin Krka 10 mg/40 mg filmom obložene tablete
| Name | Ezetimib/atorvastatin Krka 10 mg/40 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-053648061 |
| Active Substance | atorvastatinkalcij trihidrat ezetimib |
| Composition | jedna filmom obložena tableta sadrži 10 mg ezetimiba i 40 mg atorvastatina (u obliku atorvastatinkalcijevog trihidrata) |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | TAD Pharma Gmbh, Cuxhaven, Njemačka
Krka d.d., Novo mesto, Novo Mesto, Slovenija |
| Marketing Authorisation Holder | Krka d.d., Novo mesto, Šmarješka cesta 6, Novo Mesto, Slovenija |
| Marketing Authorisation Date | 08.11.2024 |
| MA Period of Validity | 08.11.2029 |
| Classification Number | UP/I-530-09/23-01/292 |
| Registration Number | 381-12-01/70-24-08 |
| 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 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
