| Name |
octaplasLG 45-70 mg/ml prašak i otapalo za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-223252057 |
| Active Substance |
ljudska plazma |
| Composition |
jedna bočica s praškom sadrži 9 - 14 g proteina ljudske plazme specifičnih za krvne grupe AB0. Nakon rekonstitucije sa 190 ml otapala, otopina sadrži 45-70 mg/ml proteina ljudske plazme specifičnih za krvne grupe AB0 |
| Pharmaceutical Form |
Prašak i otapalo za otopinu za infuziju |
| Manufacturer |
Octapharma AB, Stockholm, Švedska |
| Marketing Authorisation Holder |
Octapharma (IP) SPRL, Allee De La Recherche 65, Anderlecht, Belgija |
| Marketing Authorisation Date |
21.02.2023 |
| MA Period of Validity |
21.02.2028 |
| Classification Number |
UP/I-530-09/21-01/347 |
| Registration Number |
381-12-01/171-23-09 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
B05AA |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
