| Name |
Apremilast Sandoz 10 mg, 20 mg i 30 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-734555203 |
| 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 |
Rontis Hellas Medical and Pharmaceutical Products S.A., Larissa, Grčka |
| Marketing Authorisation Holder |
Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date |
04.09.2025 |
| MA Period of Validity |
04.09.2030 |
| Classification Number |
UP/I-530-09/25-01/136 |
| Registration Number |
381-12-01/171-25-09 |
| 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 |
L04AA32 |
| Marketing status |
nije stavljeno u promet |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
