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