Eribulin EVER Pharma 0,44 mg/ml otopina za injekciju
| Name | Eribulin EVER Pharma 0,44 mg/ml otopina za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-870080195 |
| Active Substance | eribulinmesilat |
| Composition | jedan ml otopine sadrži 0,44 mg eribulina u obliku eribulinmesilata jedna bočica od 2 ml sadrži 0,88 mg eribulina u obliku eribulinmesilata jedna bočica od 3 ml sadrži 1,32 mg eribulina u obliku eribulinmesilata |
| Pharmaceutical Form | otopina za injekciju |
| Manufacturer | oncomed manufacturing a.s., Brno-Rečkovice, Češka
Ever Pharma Jena GmbH, Jena, Njemačka |
| Marketing Authorisation Holder | EVER Valinject GmbH, Oberburgau 3, Unterach am Attersee, Austrija |
| Marketing Authorisation Date | 09.05.2024 |
| MA Period of Validity | 09.05.2029 |
| Classification Number | UP/I-530-09/22-01/296 |
| Registration Number | 381-12-01/70-24-08 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | L01XX41 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
