Midazolam hameln 5 mg/ml otopina za injekciju/infuziju
| Name | Midazolam hameln 5 mg/ml otopina za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-799453923 |
| Active Substance | midazolamklorid |
| Composition | 1 ml otopine sadrži 5,56 mg midazolamklorida što odgovara 5 mg midazolama svaka ampula od 1 ml, 2 ml, 3 ml, 5 ml, 10 ml ili 18 ml sadrži 5 mg, 10 mg, 15 mg, 25 mg, 50 mg ili 90 mg midazolama |
| Pharmaceutical Form | Otopina za injekciju / infuziju |
| Manufacturer | Siegfried Hameln GmbH, Hameln, Njemačka HBM Pharma s.r.o., Martin, Slovačka hameln rds s.r.o., Modra, Slovačka Zaklady Farmaceutyczne Polpharma S.A., Starogard Gdanski, Poljska |
| Marketing Authorisation Holder | hameln pharma GmbH, Inselstrasse 1, Hameln, Njemačka |
| Marketing Authorisation Date | 16.06.2021 |
| MA Period of Validity | 16.06.2026 |
| Classification Number | UP/I-530-09/20-01/313 |
| Registration Number | 381-12-01/154-21-02 |
| 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 |
