Fibryga 1 g prašak i otapalo za otopinu za injekciju/infuziju
Name | Fibryga 1 g prašak i otapalo za otopinu za injekciju/infuziju |
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Marketing Authorisation Number | HR-H-074022622 |
Active Substance | fibrinogen, ljudski |
Composition | Jedna bočica Fibryge sadrži 1 g ljudskog fibrinogena. Nakon rekonstitucije s 50 ml vode za injekciju Fibryga sadrži približno 20 mg/ml ljudskog fibrinogena. |
Pharmaceutical Form | Prašak i otapalo za otopinu za injekciju / infuziju |
Manufacturer | Octapharma Pharmazeutika Produktionsges.m.b.H., Beč, Austrija Octapharma AB, Stockholm, Švedska |
Marketing Authorisation Holder | Jana Pharm d.o.o., Lopašićeva 6, Zagreb, Hrvatska |
Marketing Authorisation Date | 10.01.2022 |
MA Period of Validity | unlimited |
Classification Number | UP/I-530-09/21-02/126 |
Registration Number | 381-12-01/154-22-04 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | B02BB01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |