Abirateron Sandoz 500 mg filmom obložene tablete
| Name | Abirateron Sandoz 500 mg filmom obložene tablete |
|---|---|
| Marketing Authorisation Number | HR-H-328523636 |
| Active Substance | abirateronacetat |
| Composition | svaka filmom obložena tableta sadrži 500 mg abirateronacetata |
| Pharmaceutical Form | filmom obložena tableta |
| Manufacturer | Remedica Ltd., Limassol, Cipar
Lek Pharmaceuticals d.d., Ljubljana, Slovenija |
| Marketing Authorisation Holder | Sandoz d.o.o., Maksimirska 120, Zagreb, Hrvatska |
| Marketing Authorisation Date | 01.07.2021 |
| MA Period of Validity | 01.07.2026 |
| Classification Number | UP/I-530-09/19-01/272 |
| Registration Number | 381-12-01/154-21-02 |
| Prescription | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L02BX03 |
| Marketing status | trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
