Name |
Kolistin Zentiva 1 milijun IU prašak za otopinu za injekciju/infuziju |
Former Name |
Kolistin Alvogen 1 milijun IU prašak za otopinu za injekciju/infuziju |
Marketing Authorisation Number |
HR-H-458384293 |
Active Substance |
kolistimetatnatrij |
Composition |
jedna bočica sadrži 1 milijun internacionalnih jedinica (IU) kolistimetatnatrija |
Pharmaceutical Form |
Prašak za otopinu za injekciju / infuziju |
Manufacturer |
Xellia Pharmaceuticals ApS, Kopenhagen S, Danska |
Marketing Authorisation Holder |
Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
Marketing Authorisation Date |
08.04.2022 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/17-02/235 |
Registration Number |
381-12-01/154-22-20 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
J01XB01 |
Medicinal product marketed in the Croatia |
Trajni prekid opskrbe |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|