Beriate 2000 IU prašak i otapalo za otopinu za injekciju ili infuziju
| Name | Beriate 2000 IU prašak i otapalo za otopinu za injekciju ili infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-856167715 |
| Active Substance | koagulacijski faktor VIII, ljudski |
| Composition | jedna bočica sadrži 2000 IU humanog koagulacijskog faktora VIII (FVIII); nakon rekonstitucije s 10 ml otapala sadrži približno 200 IU/ml faktora VIII |
| Pharmaceutical Form | prašak i otapalo za otopinu za injekciju ili infuziju |
| Manufacturer | CSL Behring GmbH, Marburg, Njemačka |
| Marketing Authorisation Holder | CSL Behring GmbH, Emil-von-Behring-Str. 76, Marburg, Njemačka |
| Marketing Authorisation Date | 22.09.2017 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/17-02/74 |
| Registration Number | 381-12-01/70-17-02 |
| 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 | B02BD02 |
| Marketing status | nije stavljeno u promet |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
