Midazolam Kalceks 5 mg/ml otopina za injekciju/infuziju
| 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 | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N05CD08 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
