Orebriton 90 mg filmom obložene tablete
| Name | Orebriton 90 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-197627661 |
| Active Substance | tikagrelor |
| Composition | jedna filmom obložena tableta sadrži 90 mg tikagrelora |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Labormed - Pharma S.A., 3rd District, Bukurešt, Rumunjska Alvogen Malta (Out-Licensing) Ltd., San Gwann, Malta |
| Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date | 15.03.2022 |
| MA Period of Validity | 15.03.2027 |
| Classification Number | UP/I-530-09/21-01/18 |
| Registration Number | 381-12-01/70-22-02 |
| 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 | B01AC24 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
