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 |
| 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 | Medicinal product subject to medical prescription |
| Type of prescription | ponovljivi recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | B01AF01 |
| Marketing status | nije stavljeno u promet |
| 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 Runaplax |
