Apiksaban Teva 5 mg filmom obložene tablete
| Name | Apiksaban Teva 5 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-716911265 |
| Active Substance | apiksaban |
| Composition | jedna filmom obložena tableta sadrži 5 mg apiksabana |
| Pharmaceutical Form | Filmom obložena tableta |
| Packaging [MA Number for Packaging] | 14 tableta u blisteru, u kutiji [HR-H-716911265-01] 20 tableta u blisteru, u kutiji [HR-H-716911265-02] 28 tableta u blisteru, u kutiji [HR-H-716911265-03] 56 tableta u blisteru, u kutiji [HR-H-716911265-04] 60 tableta u blisteru, u kutiji [HR-H-716911265-05] 100 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-716911265-06] 168 tableta u blisteru, u kutiji [HR-H-716911265-07] 200 tableta u blisteru, u kutiji [HR-H-716911265-08] 60 tableta u bočici, u kutiji [HR-H-716911265-09] 30 tableta u blisteru, u kutiji [HR-H-716911265-10] 100 tableta u blisteru, u kutiji [HR-H-716911265-11] 105 tableta u blisteru, u kutiji [HR-H-716911265-12] 28 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-716911265-13] 56 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-716911265-14] 60 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-716911265-15] 168 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-716911265-16] |
| Manufacturer | Combino Pharm (Malta) Ltd., Birzebbuga, Malta |
| Marketing Authorisation Holder | TEVA GmbH, Graf-Arco-Str. 3, Ulm, Njemačka |
| Marketing Authorisation Date | 05.10.2022 |
| MA Period of Validity | 05.10.2027 |
| Classification Number | UP/I-530-09/22-01/122 |
| Registration Number | 381-12-01/154-22-05 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B01AF02 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Vodič za propisivače, verzija 5 |
