| Name |
Empressin 20 IU/ 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 argipresinacetat u količini koja odgovara 40 IU argipresina (što odgovara 133 mikrograma)
1 ml koncentrata za otopinu za infuziju sadrži argipresinacetat 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 |
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 |
H01BA01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
