| Name |
Midazolam Kalceks 5 mg/ml otopina za injekciju/infuziju |
| Marketing Authorisation Number |
HR-H-123281348 |
| Active Substance |
midazolamklorid |
| Composition |
1 ml otopine sadrži 5 mg midazolama (u obliku midazolamklorida) |
| Pharmaceutical Form |
otopina za injekciju/infuziju |
| Manufacturer |
AS Kalceks, Riga, Latvija |
| Marketing Authorisation Holder |
AS Kalceks, Krustpils iela 71E, Riga, Latvija |
| Marketing Authorisation Date |
14.03.2023 |
| MA Period of Validity |
unlimited |
| Classification Number |
UP/I-530-09/22-02/148 |
| Registration Number |
381-12-01/70-23-06 |
| 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 |
N05CD08 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
