Fulvestrant Accord 250 mg otopina za injekciju u napunjenoj štrcaljki
| Name | Fulvestrant Accord 250 mg otopina za injekciju u napunjenoj štrcaljki |
|---|---|
| Marketing Authorisation Number | HR-H-382264304 |
| Active Substance | fulvestrant |
| Composition | jedna napunjena štrcaljka sadrži 250 mg fulvestranta u 5 ml otopine |
| Pharmaceutical Form | otopina za injekciju u napunjenoj štrcaljki |
| Manufacturer | Accord Healthcare Polska Sp. z o.o., Pabianice, Poljska Pharmadox Healthcare Limited, Paola, Malta |
| Marketing Authorisation Holder | Accord Healthcare Polska Sp. z o.o., Ul. Tasmowa 7, Mazowieckie, Varšava, Poljska |
| Marketing Authorisation Date | 18.08.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/21-02/216 |
| Registration Number | 381-12-01/70-22-04 |
| 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 | L02BA03 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
