Name |
Dormicum 15 mg/3 ml otopina za injekciju/infuziju |
Former Name |
Dormicum 15 mg/3 ml otopina za injekciju |
Marketing Authorisation Number |
HR-H-950365768 |
Active Substance |
midazolamklorid |
Composition |
1 ml otopine sadrži 5 mg midazolama (u obliku midazolamklorida) |
Pharmaceutical Form |
otopina za injekciju/infuziju |
Manufacturer |
Cenexi, Fontenay-sous-Bois, Francuska |
Marketing Authorisation Holder |
Cheplapharm Arzneimittel GmbH, Ziegelhof 24, Greifswald, Njemačka |
Marketing Authorisation Date |
01.06.2020 |
MA Period of Validity |
unlimited |
Classification Number |
UP/I-530-09/14-02/108 |
Registration Number |
381-12-01/70-20-42 |
Prescription |
Medicinal product subject to medical prescription |
Type of prescription |
ograničeni recept
|
Distribution |
Supply through pharmacies (community) |
Advertising to general public |
not allowed |
ATC Code |
N05CD08 |
Marketing status |
stavljeno u promet |
Shortage status |
nema nestašice |
SmPC |
download |
PL |
download |