Medicinal Products

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
Back