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 |
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 |
Medicinal product subject to medical prescription |
Type of prescription |
ograničeni recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
V03AC03 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|
Summary of risk management plan |
download |