Immunate 500 IU FVIII/375 IU vWF prašak i otapalo za otopinu za injekciju
| Name | Immunate 500 IU FVIII/375 IU vWF prašak i otapalo za otopinu za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-927359696 |
| Active Substance | koagulacijski faktor VIII, ljudski von Willebrandov faktor, ljudski |
| Composition | jedna bočica nominalno sadrži 500 IU ljudskog koagulacijskog faktora VIII i 375 IU ljudskog von Willebrandovog faktora (vWF:RCo) |
| Pharmaceutical Form | prašak i otapalo za otopinu za injekciju |
| Manufacturer | Takeda Manufacturing Austria AG, Beč, Austrija |
| Marketing Authorisation Holder | Baxalta Innovations GmbH, Industriestrasse 67, Beč, Austrija |
| Marketing Authorisation Date | 08.02.2019 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/14-02/301 |
| Registration Number | 381-12-01/70-19-51 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | B02BD06 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
