Rivaroksaban Teva 10 mg filmom obložene tablete
| Name | Rivaroksaban Teva 10 mg filmom obložene tablete |
|---|---|
| Former Name | Rivaroksaban Pliva 10 mg filmom obložene tablete |
| Marketing Authorisation Number | HR-H-821194254 |
| Active Substance | rivaroksaban |
| Composition | jedna filmom obložena tableta sadrži 10 mg rivaroksabana |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska Actavis Group PTC ehf., Hafnarfjoerdur, Island |
| Marketing Authorisation Holder | Teva GmbH, Graf-Arco-Strasse 3, Ulm, Njemačka |
| Marketing Authorisation Date | 10.09.2025 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/25-02/31 |
| Registration Number | 381-12-01/70-25-06 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | Medicinal product on medical prescription for renewable delivery |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | B01AF01 |
| Marketing status | Marketed |
| Shortage status | Actual |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
| Educational materials for healthcare professionals |
Vodič za liječnike s informacijama o primjeni rivaroksabana, verzija 1 |
| Educational materials for patients / caregivers |
Kartica s upozorenjima za bolesnika Rivaroksaban Teva |
