Name |
Kolistin Zentiva 2 milijuna IU prašak za otopinu za injekciju, infuziju ili inhalaciju |
Former Name |
Kolistin Alvogen 2 milijuna IU prašak za otopinu za injekciju, infuziju ili inhalaciju |
Marketing Authorisation Number |
HR-H-403895480 |
Active Substance |
kolistimetatnatrij |
Composition |
svaka bočica sadrži 2 milijuna internacionalnih jedinica (IU) kolistimetatnatrija |
Pharmaceutical Form |
prašak za otopinu za injekciju, infuziju ili inhalaciju |
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-530-09/21-02/132 |
Registration Number |
381-12-01/154-22-25 |
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 |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|