| 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 |
18.03.2025 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/24-02/148 |
| Registration Number |
381-12-01/171-25-05 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
L02BA03 |
| Marketing status |
Marketed |
| Shortage status |
Actual |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
