| Name |
Bendamustin Kabi 2,5 mg/ml prašak za koncentrat za otopinu za infuziju |
| 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 |
Medicinal product subject to medical prescription |
| Type of prescription |
ograničeni recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
L01AA09 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
