Dapagliflozin/metforminklorid Krka 5 mg/850 mg filmom obložene tablete
| Name | Dapagliflozin/metforminklorid Krka 5 mg/850 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-016003153 |
| Active Substance | dapagliflozin propandiol hidrat metforminklorid |
| Composition | jedna filmom obložena tableta sadrži 5 mg dapagliflozina (u obliku dapagliflozin propandiol hidrata) i 850 mg metforminklorida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Krka d.d. Novo mesto, Novo Mesto, Slovenija
TAD Pharma Gmbh, Cuxhaven, Njemačka |
| Marketing Authorisation Holder | Krka d.d. Novo mesto, Šmarješka cesta 6, Novo Mesto, Slovenija |
| Marketing Authorisation Date | 22.08.2025 |
| MA Period of Validity | 22.08.2030 |
| Classification Number | UP/I-530-09/24-01/121 |
| Registration Number | 381-12-01/171-25-12 |
| 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 | A10BD15 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
