| Name |
Bosutinib Onkogen 100 mg filmom obložene tablete |
| Marketing Authorisation Number |
HR-H-142443843 |
| Active Substance |
bosutinib |
| Composition |
jedna filmom obložena tableta sadrži 100 mg bosutiniba |
| Pharmaceutical Form |
Filmom obložena tableta |
| Manufacturer |
Coripharma ehf., Hafnarfjoerdur, Island |
| Marketing Authorisation Holder |
Onkogen Kft., Becsi Ut 77-79, Budimpešta, Mađarska |
| Marketing Authorisation Date |
08.11.2024 |
| MA Period of Validity |
08.11.2029 |
| Classification Number |
UP/I-530-09/24-01/23 |
| Registration Number |
381-12-01/70-24-07 |
| 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 |
L01EA04 |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
