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 |
Packaging [MA Number for Packaging] | 5 ampula s 1 ml otopine, u kutiji [HR-H-123281348-01] 10 ampula s 1 ml otopine, u kutiji [HR-H-123281348-02] 5 ampula s 3 ml otopine, u kutiji [HR-H-123281348-03] 10 ampula s 3 ml otopine, u kutiji [HR-H-123281348-04] 5 ampula s 10 ml otopine, u kutiji [HR-H-123281348-05] 10 ampula s 10 ml otopine, u kutiji [HR-H-123281348-06] |
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 |