Jamesi 50 mg/1000 mg filmom obložene tablete
| Name | Jamesi 50 mg/1000 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-465042715 |
| Active Substance | sitagliptinklorid hidrat metforminklorid |
| Composition | svaka filmom obložena tableta sadrži 50 mg sitagliptina u obliku sitagliptinklorid hidrata i 1000 mg metforminklorida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Laboratorios Liconsa S.A., Azuqueca de Henares, Guadalajara, Španjolska |
| Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date | 24.03.2022 |
| MA Period of Validity | 24.03.2027 |
| MA Revocation Date | 11.06.2026* |
| Classification Number | UP/I-530-09/20-01/139 |
| Registration Number | 381-12-01/154-22-02 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | A10BD07 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act, only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
