| Name |
Bendamustin Teva 2,5 mg/ml prašak za koncentrat za otopinu za infuziju |
| Former Name |
Bendamustin Actavis 2,5 mg/ml prašak za koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-831944969 |
| Active Substance |
bendamustinklorid |
| Composition |
1 ml koncentrata sadrži 2,5 mg bendamustinklorid nakon rekonstitucije jedna bočica od 26 ml sadrži 25 mg bendamustinklorida jedna bočica od 60 ml sadrži 100 mg bendamustinklorida |
| Pharmaceutical Form |
prašak za koncentrat za otopinu za infuziju |
| Manufacturer |
S.C. Sindan-Pharma S.R.L., Bukurešt, Rumunjska |
| Marketing Authorisation Holder |
Teva B.V., Swensweg 5, Haarlem, Nizozemska |
| Marketing Authorisation Date |
11.08.2021 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/19-02/84 |
| Registration Number |
381-12-01/70-21-13 |
| 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 |
Nestašica |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
