Glerova 50 mg/1000 mg filmom obložene tablete
| Name | Glerova 50 mg/1000 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-297560295 |
| Active Substance | sitagliptinklorid hidrat metforminklorid |
| Composition | jedna filmom obložena tableta sadrži 50 mg sitagliptina u obliku sitagliptinklorid hidrata i 1000 mg metforminklorida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Medis International A.S., Bolatice, Češka
Mylan Hungary Kft, Komárom, Mađarska McDermott Laboratories Limited, t/a Gerard Laboratories, Dublin 13, Irska |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin 15, Irska |
| Marketing Authorisation Date | 22.03.2022 |
| MA Period of Validity | 17.02.2027 |
| Classification Number | UP/I-530-09/20-01/263 |
| Registration Number | 381-12-01/70-22-09 |
| 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 |
