Cloter 15 mg filmom obložene tablete
| Name | Cloter 15 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-131622981 |
| 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, u kutiji [HR-H-131622981-01] 14 tableta u blisteru, u kutiji [HR-H-131622981-02] 28 tableta u blisteru, u kutiji [HR-H-131622981-03] 30 tableta u blisteru, u kutiji [HR-H-131622981-04] 42 tablete u blisteru, u kutiji [HR-H-131622981-05] 50 tableta u blisteru, u kutiji [HR-H-131622981-06] 98 tableta u blisteru, u kutiji [HR-H-131622981-07] 100 tableta u blisteru, u kutiji [HR-H-131622981-08] |
| Manufacturer | PharOS MT Ltd, Birzebbugia, Malta Genericon Pharma Gesellschaft m.b.H., Graz, Austrija Rontis Hellas Medical and Pharmaceutical Products S.A., Larisa, Grčka |
| Marketing Authorisation Holder | Genericon Pharma Gesellschaft m.b.H., Hafnerstraße 211, Graz, Austrija |
| Marketing Authorisation Date | 30.08.2023 |
| MA Period of Validity | 30.08.2028 |
| Classification Number | UP/I-530-09/22-01/213 |
| Registration Number | 381-12-01/70-23-07 |
| 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 Cloter |
