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 |
|---|---|
| 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 |
