| Name |
Roxofor 360 mg filmom obložene tablete |
| Former Name |
Deferasiroks Alpha-Medical 360 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-861848080 |
| Active Substance |
deferasiroks |
| Composition |
svaka filmom obložena tableta sadrži 360 mg deferasiroksa |
| Pharmaceutical Form |
filmom obložena tableta |
| Packaging [MA Number for Packaging] |
30 tableta u blisteru, u kutiji [HR-H-861848080-01]
|
| Manufacturer |
PharOS MT Ltd, Birzebbugia, Malta |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
30.04.2020 |
| MA Period of Validity |
30.04.2025 |
| Classification Number |
UP/I-530-09/18-01/264 |
| Registration Number |
381-12-01/30-20-05 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
V03AC03 |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
