| Name |
Amikacin Zentiva 250 mg/ml otopina za injekciju/infuziju |
| Former Name |
Amikacin Alvogen 250 mg/ml otopina za injekciju/infuziju |
| Marketing Authorisation Number |
HR-H-340774212 |
| Active Substance |
amikacinsulfat |
| Composition |
1 ml otopine sadrži 250 mg amikacina (u obliku sulfata)
jedna bočica od 2 ml otopine sadrži 500 mg amikacina (u obliku sulfata) |
| Pharmaceutical Form |
Otopina za injekciju / infuziju |
| Manufacturer |
Anfarm Hellas S.A., Schimatari Viotias, Grčka |
| Marketing Authorisation Holder |
Zentiva k.s., U Kabelovny 130, Dolni Mecholupy, Prag 10, Češka |
| Marketing Authorisation Date |
31.10.2023 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/23-02/17 |
| Registration Number |
381-12-01/70-23-04 |
| 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 |
J01GB06 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
