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 |