Bendamustin PharmaS 2,5 mg/ml prašak za koncentrat za otopinu za infuziju
Name | Bendamustin PharmaS 2,5 mg/ml prašak za koncentrat za otopinu za infuziju |
---|---|
Marketing Authorisation Number | HR-H-823301419 |
Active Substance | bendamustinklorid hidrat |
Composition | jedna bočica sadrži 25 mg bendamustinklorida (u obliku bendamustinklorid hidrata) jedna bočica sadrži 100 mg bendamustinklorida (u obliku bendamustinklorid hidrata) nakon rekonstitucije 1 ml koncentrata sadrži 2,5 mg bendamustinklorida |
Pharmaceutical Form | prašak za koncentrat za otopinu za infuziju |
Manufacturer | Synthon Hispania S.L., Barcelona, Španjolska Synthon s.r.o., Blansko, Češka |
Marketing Authorisation Holder | PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska |
Marketing Authorisation Date | 05.07.2021 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/20-02/70 |
Registration Number | 381-12-01/154-21-08 |
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 |