Orebriton 60 mg filmom obložene tablete
| Name | Orebriton 60 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-395630141 |
| Active Substance | tikagrelor |
| Composition | jedna filmom obložena tableta sadrži 60 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-530-09/21-01/17 |
| Registration Number | 381-12-01/70-22-04 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B01AC24 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
