Fulvestrant AptaPharma 250 mg otopina za injekciju u napunjenoj štrcaljki
| Name | Fulvestrant AptaPharma 250 mg otopina za injekciju u napunjenoj štrcaljki |
|---|---|
| Marketing Authorisation Number | HR-H-804002250 |
| Active Substance | fulvestrant |
| Composition | jedna napunjena štrcaljka sadrži 250 mg fulvestranta u 5 ml otopine |
| Pharmaceutical Form | otopina za injekciju u napunjenoj štrcaljki |
| Manufacturer | Laboratorios Farmalán, S.A., León, Španjolska |
| Marketing Authorisation Holder | Apta Medica Internacional d.o.o., Likozarjeva ulica 6, Ljubljana, Slovenija |
| Marketing Authorisation Date | 15.09.2020 |
| MA Period of Validity | 15.09.2025 |
| Classification Number | UP/I-530-09/20-01/08 |
| Registration Number | 381-12-01/38-20-04 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L02BA03 |
| Medicinal product marketed in the Croatia | Nestašica |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
