Benmak 2,5 mg/ml prašak za koncentrat za otopinu za infuziju
Name | Benmak 2,5 mg/ml prašak za koncentrat za otopinu za infuziju |
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Marketing Authorisation Number | HR-H-537845706 |
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) |
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 | Makpharm d.o.o., Trnjanska cesta 37/1, Zagreb, Hrvatska |
Marketing Authorisation Date | 03.12.2019 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/19-02/176 |
Registration Number | 381-12-01/38-19-04 |
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 |