Midazolam hameln 2 mg/ml otopina za injekciju/infuziju
| Name | Midazolam hameln 2 mg/ml otopina za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-139324339 |
| Active Substance | midazolamklorid |
| Composition | 1 ml otopine sadrži 2,22 mg midazolamklorida što odgovara 2 mg midazolama svaka ampula/bočica od 5 ml, 25 ml ili 50 ml sadrži 10 mg, 50 mg ili 100 mg midazolama |
| Pharmaceutical Form | Otopina za injekciju / infuziju |
| Manufacturer | HBM Pharma s.r.o., Martin, Slovačka Siegfried Hameln GmbH, Hameln, Njemačka 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-530-09/20-01/312 |
| 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 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
