| 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 |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
J01FA10 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
