Fulvestrant AptaPharma 250 mg otopina za injekciju u napunjenoj štrcaljki
Name | Fulvestrant AptaPharma 250 mg otopina za injekciju u napunjenoj štrcaljki |
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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 |