Runaplax 15 mg filmom obložene tablete
| Name | Runaplax 15 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-918282060 |
| Active Substance | rivaroksaban |
| Composition | svaka filmom obložena tableta sadrži 15 mg rivaroksabana |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 5 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-918282060-01] 10 tableta u blisteru, u kutiji [HR-H-918282060-02] 10 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-918282060-03] 14 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-918282060-04] 20 tableta u blisteru, u kutiji [HR-H-918282060-05] 28 tableta u blisteru, u kutiji [HR-H-918282060-06] 30 tableta u blisteru, u kutiji [HR-H-918282060-07] 42 tablete u blisteru, u kutiji [HR-H-918282060-08] 50 tableta u blisteru, u kutiji [HR-H-918282060-09] 98 tableta u blisteru, u kutiji [HR-H-918282060-10] 100 tableta u blisteru, u kutiji [HR-H-918282060-11] 100 tableta u bočici, u kutiji [HR-H-918282060-12] |
| Manufacturer | Salutas Pharma GmbH, Barleben, Njemačka |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 10.10.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/21-02/193 |
| Registration Number | 381-12-01/154-22-03 |
| 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 |
| 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 Runaplax |
