Daforbis 5 mg filmom obložene tablete
| Name | Daforbis 5 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-544705771 |
| Active Substance | dapagliflozin |
| Composition | jedna filmom obložena tableta sadrži 5 mg dapagliflozina |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Mylan Hungary Kft, Komárom, Mađarska Mylan Germany GmbH , Bad Homburg, Hesse, Njemačka |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 15.11.2023 |
| MA Period of Validity | 06.09.2028 |
| Classification Number | UP/I-530-09/22-01/33 |
| Registration Number | 381-12-01/70-23-15 |
| 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 | A10BK01 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
