Sitagliptin/metforminklorid Genericon 50 mg/1000 mg filmom obložene tablete
Name | Sitagliptin/metforminklorid Genericon 50 mg/1000 mg filmom obložene tablete |
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Marketing Authorisation Number | HR-H-024518604 |
Active Substance | sitagliptinklorid hidrat metforminklorid |
Composition | svaka tableta sadrži sitagliptinklorid hidrat u količini od 50 mg sitagliptina i 1000 mg metforminklorida |
Pharmaceutical Form | Filmom obložena tableta |
Manufacturer | PharOS MT Ltd, Birzebbugia, Malta
Rontis Hellas Medical and Pharmaceutical Products S.A., Larisa, Grčka Genericon Pharma Gesellschaft m.b.H., Graz, Austrija |
Marketing Authorisation Holder | Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, Austrija |
Marketing Authorisation Date | 17.02.2023 |
MA Period of Validity | 17.02.2028 |
Classification Number | UP/I-530-09/21-01/157 |
Registration Number | 381-12-01/38-23-07 |
Prescription | na recept |
Type of prescription | ponovljivi recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | A10BD07 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |