Rivaroksaban Teva 15 mg filmom obložene tablete
| Name | Rivaroksaban Teva 15 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-727893287 |
| Active Substance | rivaroksaban |
| Composition | jedna filmom obložena tableta sadrži 15 mg rivaroksabana |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 10 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-727893287-01] 14 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-727893287-02] 28 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-727893287-03] 30 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-727893287-04] 42 tablete u blisteru s jediničnom dozom, u kutiji [HR-H-727893287-05] 90 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-727893287-06] 98 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-727893287-07] 100 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-727893287-08] 112 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-727893287-09] 100 tableta u bočici, u kutiji [HR-H-727893287-10] 200 tableta u bočici, u kutiji [HR-H-727893287-11] |
| Manufacturer | Teva Pharma B.V., Haarlem, Nizozemska
Balkanpharma - Dupnitsa AD, Dupnitsa, Bugarska Actavis Group PTC ehf., Hafnarfjoerdur, Island |
| Marketing Authorisation Holder | TEVA GmbH, Graf-Arco-Str. 3, Ulm, Njemačka |
| Marketing Authorisation Date | 31.08.2023 |
| MA Period of Validity | 18.01.2026 |
| Classification Number | UP/I-530-09/19-01/77 |
| Registration Number | 381-12-01/70-23-21 |
| 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 |
| 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 |
