Condias Combi 50 mg/850 mg filmom obložene tablete
| Name | Condias Combi 50 mg/850 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-769185706 |
| Active Substance | sitagliptinklorid hidrat metforminklorid |
| Composition | jedna tableta sadrži sitagliptinklorid hidrat što odgovara 50 mg sitagliptina i 850 mg metforminklorida |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
| Marketing Authorisation Holder | Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
| Marketing Authorisation Date | 25.05.2023 |
| MA Period of Validity | 25.05.2028 |
| MA Revocation Date | 05.02.2026* |
| Classification Number | UP/I-530-09/22-01/86 |
| Registration Number | 381-12-01/70-23-10 |
| 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 | Never marketed |
| 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Marketing authorisation has been revoked by request of the marketing authorisation holder.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 (Official Gazette No. 76/13), 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.
