Enzalutamid Sandoz 80 mg filmom obložene tablete
Name | Enzalutamid Sandoz 80 mg filmom obložene tablete |
---|---|
Marketing Authorisation Number | HR-H-807784657 |
Active Substance | enzalutamid |
Composition | svaka filmom obložena tableta sadrži 80 mg enzalutamida. |
Pharmaceutical Form | Filmom obložena tableta |
Manufacturer | Lek Pharmaceuticals d.d., Ljubljana, Slovenija Lek Pharmaceuticals d.d., Lendava, Slovenija |
Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
Marketing Authorisation Date | 18.08.2023 |
MA Period of Validity | 18.08.2028 |
Classification Number | UP/I-530-09/23-01/82 |
Registration Number | 381-12-01/70-23-05 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L02BB04 |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |