| 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 |
| Packaging [MA Number for Packaging] |
5 ampula sa 3 ml otopine, u kutiji [HR-H-950365768-01]
|
| 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 |
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 |
