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 | Medicinal product subject to medical prescription |
| Type of prescription | ograničeni recept |
| Distribution | Supply through pharmacies (community) |
| Advertising to general public | not allowed |
| ATC Code | L01AA09 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
