| Name |
Apremilast Belupo 10 mg i 20 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-292103836 |
| Active Substance |
apremilast |
| Composition |
jedna filmom obložena tableta sadrži 10 mg apremilasta jedna filmom obložena tableta sadrži 20 mg apremilasta |
| Pharmaceutical Form |
Filmom obložena tableta |
| Manufacturer |
Belupo lijekovi i kozmetika d.d., Koprivnica, Hrvatska |
| Marketing Authorisation Holder |
Belupo lijekovi i kozmetika d.d., Ulica Danica 5, Koprivnica, Hrvatska |
| Marketing Authorisation Date |
27.02.2026 |
| MA Period of Validity |
27.02.2031 |
| Classification Number |
UP/I-530-09/24-01/424 |
| Registration Number |
381-12-01/70-26-09 |
| 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 |
