| Name |
Jazeta 25 mg/ml oralna otopina |
| Marketing Authorisation Number |
HR-H-579921736 |
| Active Substance |
sitagliptinklorid hidrat |
| Composition |
1 ml oralne otopine sadrži sitagliptinklorid hidrat što odgovara 25 mg sitagliptina |
| Pharmaceutical Form |
Oralna otopina |
| Manufacturer |
Labomed Pharmaceutical Company S.A., Koropi, Attica, Grčka |
| Marketing Authorisation Holder |
Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date |
08.09.2022 |
| MA Period of Validity |
08.09.2027 |
| Classification Number |
UP/I-530-09/20-01/162 |
| Registration Number |
381-12-01/38-22-13 |
| 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 |
A10BH01 |
| Marketing status |
nije stavljeno u promet |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
