Jamesi 50 mg/850 mg filmom obložene tablete
| Name | Jamesi 50 mg/850 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-340683888 |
| Active Substance | sitagliptinklorid hidrat metforminklorid |
| Composition | svaka filmom obložena tableta sadrži 50 mg sitagliptina u obliku sitagliptinklorid hidrata i 850 mg metforminklorida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Laboratorios Liconsa S.A., Azuqueca de Henares, Guadalajara, Španjolska |
| Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date | 24.03.2022 |
| MA Period of Validity | 24.03.2027 |
| Classification Number | UP/I-530-09/20-01/138 |
| Registration Number | 381-12-01/154-22-04 |
| 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 | A10BD07 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
