Daforbis 10 mg filmom obložene tablete
Name | Daforbis 10 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-807526798 |
Active Substance | dapagliflozin |
Composition | jedna filmom obložena tableta sadrži 10 mg dapagliflozina |
Pharmaceutical Form | Filmom obložena tableta |
Manufacturer | Mylan Germany GmbH , Bad Homburg, Hesse, Njemačka Mylan Hungary Kft, Komárom, Mađarska |
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-530-09/22-01/34 |
Registration Number | 381-12-01/70-23-11 |
Prescription | na recept |
Type of prescription | ponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | A10BK01 |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |