Dasatinib Alpha-Medical 100 mg filmom obložene tablete
| Name | Dasatinib Alpha-Medical 100 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-495619877 |
| Active Substance | dasatinib |
| Composition | jedna filmom obložena tableta sadrži 100 mg dasatiniba |
| Pharmaceutical Form | filmom obložena tableta |
| Packaging [MA Number for Packaging] | 30 tableta u blisteru, u kutiji [HR-H-495619877-01] 30 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-495619877-02] 30 tableta u bočici, u kutiji [HR-H-495619877-03] 60 tableta u blisteru, u kutiji [HR-H-495619877-04] 120 tableta u blisteru, u kutiji [HR-H-495619877-05] |
| Manufacturer | Synthon Hispania S.L., Barcelona, Španjolska Synthon BV, Nijmegen, Nizozemska |
| Marketing Authorisation Holder | Alpha-Medical d.o.o., Dragutina Golika 36, Zagreb, Hrvatska |
| Marketing Authorisation Date | 29.11.2019 |
| MA Period of Validity | 29.11.2024 |
| Classification Number | UP/I-530-09/18-01/225 |
| Registration Number | 381-12-01/30-19-02 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01XE06 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
