Midazolam Kalceks 1 mg/ml otopina za injekciju/infuziju
Name | Midazolam Kalceks 1 mg/ml otopina za injekciju/infuziju |
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Marketing Authorisation Number | HR-H-883715895 |
Active Substance | midazolamklorid |
Composition | 1 ml otopine sadrži 1 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 | 03.09.2021 |
MA Period of Validity | 03.09.2026 |
Classification Number | UP/I-530-09/20-01/217 |
Registration Number | 381-12-01/14-21-05 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | N05CD08 |
SmPC | download |
PL | download |
Public Assessment Report | download |