| Name |
Aperzyx 10 mg, 20 mg i 30 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-663770454 |
| Active Substance |
apremilast |
| Composition |
jedna filmom obložena tableta sadrži 10 mg apremilasta
jedna filmom obložena tableta sadrži 20 mg apremilasta
jedna filmom obložena tableta sadrži 30 mg apremilasta |
| Pharmaceutical Form |
Filmom obložena tableta |
| Manufacturer |
Labormed - Pharma S.A., 3rd District, Bukurešt, Rumunjska |
| Marketing Authorisation Holder |
Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date |
31.01.2025 |
| MA Period of Validity |
31.01.2030 |
| Classification Number |
UP/I-530-09/23-01/319 |
| Registration Number |
381-12-01/70-25-13 |
| 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 |
L04AA32 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
