| Name |
Ruksolitinib Devatis 15 mg tablete |
| Marketing Authorisation Number |
HR-H-671798728 |
| Active Substance |
ruksolitinibhemifumarat |
| Composition |
jedna tableta sadrži 15 mg ruksolitiniba (u obliku hemifumarata) |
| Pharmaceutical Form |
Tableta |
| Manufacturer |
Devatis GmbH, Loerrach, Njemačka |
| Marketing Authorisation Holder |
Devatis GmbH, Spitalstrasse 22, Loerrach, Njemačka |
| Marketing Authorisation Date |
12.08.2026 |
| MA Period of Validity |
12.08.2031 |
| Classification Number |
UP/I-530-09/25-01/49 |
| Registration Number |
381-12-01/171-26-09 |
| 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 |
