Apiksaban Pliva 2,5 mg filmom obložene tablete
| Name | Apiksaban Pliva 2,5 mg filmom obložene tablete |
|---|---|
| Former Name | Apiksaban Teva 2,5 mg filmom obložene tablete |
| Marketing Authorisation Number | HR-H-925615454 |
| Active Substance | apiksaban |
| Composition | jedna filmom obložena tableta sadrži 2,5 mg apiksabana |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Teva Pharma B.V., Haarlem, Nizozemska
Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska |
| Marketing Authorisation Holder | Pliva Hrvatska d.o.o., Prilaz baruna Filipovića 25, Zagreb, Hrvatska |
| Marketing Authorisation Date | 09.03.2022 |
| MA Period of Validity | 10.11.2025 |
| Classification Number | UP/I-530-09/19-01/126 |
| Registration Number | 381-12-01/154-22-12 |
| 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 | B01AF02 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
