Dalzior Plus 100 mg/10 mg filmom obložene tablete
| Name | Dalzior Plus 100 mg/10 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-502232542 |
| Active Substance | sitagliptinklorid hidrat dapagliflozin |
| Composition | jedna filmom obložena tableta sadrži 100 mg sitagliptina (u obliku sitagliptinklorid hidrata) i 10 mg dapagliflozina (u obliku amorfne baze dapagliflozina) |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Rontis Hellas Medical and Pharmaceutical Products S.A., Larissa, Grčka |
| Marketing Authorisation Holder | Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date | 23.02.2026 |
| MA Period of Validity | 23.02.2031 |
| Classification Number | UP/I-530-09/24-01/267 |
| Registration Number | 381-12-01/171-26-11 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | A10BD29 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
