Rivaroksaban Zentiva 20 mg filmom obložene tablete
| Name | Rivaroksaban Zentiva 20 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-753253248 |
| Active Substance | rivaroksaban |
| Composition | jedna filmom obložena tableta sadrži 20 mg rivaroksabana |
| Pharmaceutical Form | Filmom obložena tableta |
| Packaging [MA Number for Packaging] | 10 tableta u blisteru, u kutiji [HR-H-753253248-01] 14 tableta u blisteru, u kutiji [HR-H-753253248-02] 28 tableta u blisteru, u kutiji [HR-H-753253248-03] 30 tableta u blisteru, u kutiji [HR-H-753253248-04] 50 tableta u blisteru, u kutiji [HR-H-753253248-05] 98 tableta u blisteru, u kutiji [HR-H-753253248-06] 100 tableta u blisteru, u kutiji [HR-H-753253248-07] |
| Manufacturer | Zentiva S.A., Bukurešt, Rumunjska
Pharmadox Healthcare Limited, Paola, Malta |
| Marketing Authorisation Holder | Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date | 15.12.2023 |
| MA Period of Validity | 15.12.2028 |
| Classification Number | UP/I-530-09/23-01/223 |
| Registration Number | 381-12-01/70-23-06 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B01AF01 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Educational materials for healthcare professionals |
Vodič za liječnike s informacijama o primjeni rivaroksabana, verzija 1 |
