Eribulin STADA 0,44 mg/ml otopina za injekciju
Name | Eribulin STADA 0,44 mg/ml otopina za injekciju |
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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 | 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 |
Summary of risk management plan | download |