Bosutinib Sandoz 500 mg filmom obložene tablete
| Name | Bosutinib Sandoz 500 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-521956258 |
| Active Substance | bosutinib dihidrat |
| Composition | jedna filmom obložena tableta sadrži 500 mg bosutiniba (u obliku bosutinib hidrata) |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Pharmadox Healthcare Limited, Paola, Malta
Salutas Pharma GmbH, Barleben, Njemačka Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 20.08.2025 |
| MA Period of Validity | 20.08.2030 |
| Classification Number | UP/I-530-09/22-01/80 |
| Registration Number | 381-12-01/70-25-09 |
| 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 | L01EA04 |
| Marketing status | Never marketed |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
