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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | B02BD02 |
Medicinal product marketed in the Croatia | Ne |
SmPC | download |
PL | download |
Public Assessment Report | download |