Bendamustin Kabi 2,5 mg/ml prašak za koncentrat za otopinu za infuziju
Name | Bendamustin Kabi 2,5 mg/ml prašak za koncentrat za otopinu za infuziju |
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Marketing Authorisation Number | HR-H-744843956 |
Active Substance | bendamustinklorid |
Composition | jedna bočica sadrži 25 mg bendamustinklorida; jedna bočica sadrži 100 mg bendamustinklorida; nakon rekonstitucije 1 ml koncentrata sadrži 2,5 mg bendamustinklorida |
Pharmaceutical Form | prašak za koncentrat za otopinu za infuziju |
Manufacturer | Fresenius Kabi Deutschland GmbH, Friedberg, Njemačka |
Marketing Authorisation Holder | Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
Marketing Authorisation Date | 22.04.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/20-02/126 |
Registration Number | 381-12-01/154-22-04 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | L01AA09 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |