| Name |
Roxofor 180 mg filmom obložene tablete |
| Former Name |
Deferasiroks Alpha-Medical 180 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-860719455 |
| Active Substance |
deferasiroks |
| Composition |
svaka filmom obložena tableta sadrži 180 mg deferasiroksa |
| Pharmaceutical Form |
filmom obložena tableta |
| Manufacturer |
PharOS MT Ltd, Birzebbugia, Malta |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
30.04.2025 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/24-02/83 |
| Registration Number |
381-12-01/14-25-05 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
V03AC03 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
preuzmi
|
| Summary of risk management plan |
download |
