Glerova 50 mg/1000 mg filmom obložene tablete
Name | Glerova 50 mg/1000 mg filmom obložene tablete |
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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, 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 | Medicinal product subject to medical prescription |
Type of prescription | ponovljivi recept |
Distribution | Supply through pharmacies (community) |
Advertising to general public | not allowed |
ATC Code | A10BD07 |
Marketing status | stavljeno u promet |
Shortage status | nema nestašice |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |