Eribulin STADA 0,44 mg/ml otopina za injekciju
| Name | Eribulin STADA 0,44 mg/ml otopina za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-546779645 |
| Active Substance | eribulinmesilat |
| Composition | jedan ml otopine sadrži 0,44 mg eribulina u obliku eribulinmesilata jedna bočica (2 ml) sadrži 0,88 mg eribulina u obliku eribulinmesilata |
| Pharmaceutical Form | otopina za injekciju |
| Manufacturer | STADA Arzneimittel AG, Bad Vilbel, Njemačka AqVida GmbH, Hamburg, Njemačka |
| Marketing Authorisation Holder | Stada d.o.o., Hercegovačka 14, Zagreb, Hrvatska |
| Marketing Authorisation Date | 10.10.2023 |
| MA Period of Validity | 10.10.2028 |
| Classification Number | UP/I-530-09/22-01/155 |
| Registration Number | 381-12-01/154-23-10 |
| 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 | L01XX41 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
