Fibryga 1 g prašak i otapalo za otopinu za injekciju/infuziju
| Name | Fibryga 1 g prašak i otapalo za otopinu za injekciju/infuziju |
|---|---|
| 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 |
