| Name |
Venbig 50 IU/ml prašak i otapalo za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-334668750 |
| Active Substance |
Imunoglobulin protiv hepatitisa B, ljudski, intravenski |
| Composition |
1 ml otopine koja se dobije rekonstitucijom praška s priloženim otapalom sadrži:
ljudski proteini 50 mg od čega ljudskih imunoglobulina najmanje 95% s protutijelima na HBs antigen (anti - HBs) ne manje od 50 IU
|
| Pharmaceutical Form |
prašak i otapalo za otopinu za infuziju |
| Manufacturer |
Kedrion S.p.A., S. Antimo (Napoli), Italija |
| Marketing Authorisation Holder |
Kedrion S.p.A., Ai Conti, Castelvecchio Pascoli, Barga (Lucca), Italija |
| Marketing Authorisation Date |
26.06.2018 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/17-02/08 |
| Registration Number |
381-12-01/70-18-15 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
J06BB04 |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
