| Name |
Ertapenem Fresenius Kabi 1 g prašak za koncentrat za otopinu za infuziju |
| Marketing Authorisation Number |
HR-H-808882188 |
| Active Substance |
ertapenemnatrij |
| Composition |
jedna bočica sadrži 1,0 g ertapenema (u obliku ertapenemnatrija) |
| Pharmaceutical Form |
prašak za koncentrat za otopinu za infuziju |
| Manufacturer |
ACS Dobfar S.p.A., Teramo, Italija |
| Marketing Authorisation Holder |
Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska |
| Marketing Authorisation Date |
03.11.2020 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/20-02/50 |
| Registration Number |
381-12-01/38-20-03 |
| 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 |
J01DH03 |
| Marketing status |
Marketed |
| Shortage status |
Actual |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
