| Name |
Berinert 500 IU prašak i otapalo za otopinu za injekciju / infuziju |
| Marketing Authorisation Number |
HR-H-828344348 |
| Active Substance |
inhibitor C1-esteraze, ljudski |
| Composition |
jedna bočica sadrži 500 IU ljudskog inhibitora C1-esteraze; nakon rekonstitucije s 10 ml otapala vode za injekciju sadrži 50 IU/ml ljudskog inhibitora C1-esteraze.
|
| Pharmaceutical Form |
Prašak i otapalo za otopinu za injekciju / infuziju |
| Manufacturer |
CSL Behring GmbH, Marburg, Njemačka |
| Marketing Authorisation Holder |
CSL Behring GmbH, Emil-von-Behring-Str. 76, Marburg, Njemačka |
| Marketing Authorisation Date |
04.02.2022 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/21-02/133 |
| Registration Number |
381-12-01/154-22-05 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
B06AC01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
