Ruksolitinib Sandoz 10 mg tablete
| Name | Ruksolitinib Sandoz 10 mg tablete |
|---|---|
| Marketing Authorisation Number | HR-H-931443313 |
| Active Substance | ruksolitinibklorid |
| Composition | jedna tableta sadrži 10 mg ruksolitiniba (u obliku ruksolitinibklorida) |
| Pharmaceutical Form | Tableta |
| Manufacturer | Coripharma ehf., Hafnarfjoerdur, Island
Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 03.07.2026 |
| MA Period of Validity | 03.07.2031 |
| Classification Number | UP/I-530-09/25-01/36 |
| Registration Number | 381-12-01/286-26-09 |
| 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 | L01EJ01 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
