| Name |
Ceftriakson Kalceks 2 g prašak za otopinu za injekciju/infuziju |
| Marketing Authorisation Number |
HR-H-964052736 |
| Active Substance |
ceftriaksonnatrij |
| Composition |
jedna bočica sadrži 2 g ceftriaksona (u obliku ceftriaksonnatrija) |
| Pharmaceutical Form |
Prašak za otopinu za injekciju / infuziju |
| Manufacturer |
AS Kalceks, Riga, Latvija |
| Marketing Authorisation Holder |
AS Kalceks, Krustpils iela 71E, Riga, Latvija |
| Marketing Authorisation Date |
20.01.2023 |
| MA Period of Validity |
20.01.2028 |
| Classification Number |
UP/I-530-09/21-01/229 |
| Registration Number |
381-12-01/171-23-07 |
| 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 |
J01DD04 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
