Ribas 15 mg filmom obložene tablete
| Name | Ribas 15 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-140615234 |
| Active Substance | rivaroksaban |
| Composition | jedna filmom obložena tableta sadrži 15 mg rivaroksabana |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 28 tableta u blisteru, u kutiji [HR-H-140615234-01] 42 tablete u blisteru, u kutiji [HR-H-140615234-02] 98 tableta u blisteru, u kutiji [HR-H-140615234-03] |
| Manufacturer | Genepharm S.A., Pallini, Attiki, Grčka
Pharmadox Healthcare Limited, Paola, Malta Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
| Marketing Authorisation Holder | Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
| Marketing Authorisation Date | 16.11.2023 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/23-02/113 |
| Registration Number | 381-12-01/171-23-02 |
| Prescription | na recept |
| Type of prescription | ponovljivi recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B01AF01 |
| Medicinal product marketed in the Croatia | Ne |
| 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 Ribas |
