Ditrax 500 mg filmom obložene tablete
| Name | Ditrax 500 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-029279030 |
| Active Substance | mikronizirana, pročišćena smjesa flavonoida koja se sastoji od 90% diosmina i 10% flavonoida izraženih kao hesperidin |
| Composition | Jedna tableta sadrži 500 mg mikroniziranih flavonoida koji se sastoje od 90 % diosmina (450 mg) i 10 % flavonoida (izraženih kao hesperidin) (50 mg). |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Mylan Hungary Kft, Komárom, Mađarska Kern Pharma S.L., Terrassa (Barcelona), Španjolska |
| Marketing Authorisation Holder | Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska |
| Marketing Authorisation Date | 02.07.2025 |
| MA Period of Validity | 02.07.2030 |
| Classification Number | UP/I-530-09/23-01/118 |
| Registration Number | 381-12-01/286-25-14 |
| 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 | C05CA53 |
| Marketing status | Marketed |
| Shortage status | No shortage |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
