Rivaroksaban Teva 10 mg filmom obložene tablete
Name | Rivaroksaban Teva 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 |
Packaging [MA Number for Packaging] | 5 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-821194254-01] 10 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-821194254-02] 28 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-821194254-03] 30 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-821194254-04] 90 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-821194254-05] 98 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-821194254-06] 100 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-821194254-07] 112 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-821194254-08] 100 tableta u bočici, u kutiji [HR-H-821194254-09] 200 tableta u bočici, u kutiji [HR-H-821194254-10] |
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-530-09/19-01/76 |
Registration Number | 381-12-01/70-23-24 |
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 |