Enzalutamid Sandoz 40 mg filmom obložene tablete
| Name | Enzalutamid Sandoz 40 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-505158799 |
| Active Substance | enzalutamid |
| Composition | svaka filmom obložena tableta sadrži 40 mg enzalutamida. |
| Pharmaceutical Form | Filmom obložena tableta |
| Manufacturer | Lek Pharmaceuticals d.d., Lendava, Slovenija Lek Pharmaceuticals d.d., Ljubljana, 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-530-09/23-01/81 |
| Registration Number | 381-12-01/70-23-07 |
| 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 |
