Name |
Azitromicin PharmaS 500 mg prašak za koncentrat za otopinu za infuziju |
Marketing Authorisation Number |
HR-H-433251666 |
Active Substance |
azitromicin dihidrat |
Composition |
jedna bočica sadrži 500 mg azitromicina (u obliku 524,1 mg azitromicin dihidrata), a rekonstitucijom se dobiva koncentrat sa 100 mg/ml azitromicina
|
Pharmaceutical Form |
prašak za koncentrat za otopinu za infuziju |
Manufacturer |
Anfarm Hellas S.A., Gerakas, Atena, Grčka |
Marketing Authorisation Holder |
PharmaS d.o.o., Radnička cesta 47, Zagreb, Hrvatska |
Marketing Authorisation Date |
09.06.2023 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/22-02/147 |
Registration Number |
381-12-01/70-23-05 |
Prescription |
na recept |
Type of prescription |
ograničeni recept
|
Distribution |
u ljekarni |
Advertising to general public |
zabranjeno |
ATC Code |
J01FA10 |
Medicinal product marketed in the Croatia |
Da |
SmPC |
download |
PL |
download |
Public Assessment Report |
download
|