| Name |
Azibiot 20 mg/ml prašak za oralnu suspenziju |
| Marketing Authorisation Number |
HR-H-471226070 |
| Active Substance |
azitromicin dihidrat |
| Composition |
1 ml oralne suspenzije sadrži 20 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-530-09/21-02/162 |
| Registration Number |
381-12-01/154-22-03 |
| 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
|
