Bosutinib MSN 500 mg filmom obložene tablete
| Name | Bosutinib MSN 500 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-067960474 |
| Active Substance | bosutinib dihidrat |
| Composition | jedna filmom obložena tableta sadrži 533,95 mg bosutinib dihidrata što odgovara 500 mg bosutiniba |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Pharmadox Healthcare Limited, Paola, Malta MSN Labs Europe Limited, Paola, Malta |
| Marketing Authorisation Holder | MSN Labs Europe Limited, Kw20a Corradino Park, Paola, Malta |
| Marketing Authorisation Date | 08.04.2025 |
| MA Period of Validity | 08.04.2030 |
| Classification Number | UP/I-530-09/23-01/152 |
| Registration Number | 381-12-01/171-25-07 |
| 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 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
