| Name |
octaplasLG 45-70 mg/ml otopina za infuziju |
| Marketing Authorisation Number |
HR-H-098600779 |
| Active Substance |
proteini ljudske plazme koji djeluju protiv inhibitora koagulacijskog faktora VIII |
| Composition |
1 ml otopine za infuziju sadrži 45-70 mg proteina ljudske plazme |
| Pharmaceutical Form |
otopina za infuziju |
| Manufacturer |
Octapharma AB, Stockholm, Švedska |
| Marketing Authorisation Holder |
Octapharma (IP) SPRL, Allee De La Recherche 65, Anderlecht, Belgija |
| Marketing Authorisation Date |
10.11.2020 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/19-02/243 |
| Registration Number |
381-12-01/154-20-05 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
B05AA |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
