Dasatinib Alpha-Medical 20 mg filmom obložene tablete
Name | Dasatinib Alpha-Medical 20 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-909996881 |
Active Substance | dasatinib |
Composition | jedna filmom obložena tableta sadrži 20 mg dasatiniba. |
Pharmaceutical Form | filmom obložena tableta |
Packaging [MA Number for Packaging] | 56 tableta u blisteru, u kutiji [HR-H-909996881-01] 60 tableta u blisteru, u kutiji [HR-H-909996881-02] 56 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-909996881-03] 60 tableta u blisteru s jediničnom dozom, u kutiji [HR-H-909996881-04] 60 tableta u bočici, u kutiji [HR-H-909996881-05] |
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-530-09/18-01/224 |
Registration Number | 381-12-01/30-19-04 |
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 |