| Name |
Empressin 40 IU/2 ml koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-796202242 |
| Active Substance |
argipresinacetat |
| Composition |
jedna ampula s 2 ml koncentrata za otopinu za infuziju sadrži argipresin acetat u količini koja odgovara 40 IU argipresina (što odgovara 133 mikrograma)
1 ml koncentrata za otopinu za infuziju sadrži argipresin acetat u količini koja odgovara 20 IU argipresina (što odgovara 66,5 mikrograma)
|
| Pharmaceutical Form |
koncentrat za otopinu za infuziju |
| Manufacturer |
AOP Orphan Pharmaceuticals GmbH, Beč, Austrija |
| Marketing Authorisation Holder |
Orpha-Devel Handels und Vertriebs GmbH, Wintergasse 85/1B, Purkersdorf, Austrija |
| Marketing Authorisation Date |
21.10.2020 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/19-02/92 |
| Registration Number |
381-12-01/30-20-05 |
| Prescription |
na recept |
| Type of prescription |
ograničeni recept
|
| Distribution |
u ljekarni |
| Advertising to general public |
zabranjeno |
| ATC Code |
H01BA01 |
| Medicinal product marketed in the Croatia |
Da |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
