Name |
Azibiot 40 mg/ml prašak za oralnu suspenziju |
Marketing Authorisation Number |
HR-H-681324227 |
Active Substance |
azitromicin dihidrat |
Composition |
1 ml oralne suspenzije sadrži 40 mg azitromicina (u obliku azitromicin dihidrata) |
Pharmaceutical Form |
prašak za oralnu suspenziju |
Manufacturer |
Krka d.d., Novo mesto, Novo Mesto, Slovenija |
Marketing Authorisation Holder |
Krka - farma d.o.o., Radnička cesta 48, Zagreb, Hrvatska |
Marketing Authorisation Date |
29.06.2022 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/21-02/163 |
Registration Number |
381-12-01/154-22-02 |
Prescription |
Medicinal product subject to medical prescription |
Type of prescription |
neponovljivi recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
J01FA10 |
Marketing status |
nije stavljeno u promet |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|