Amiodaronklorid hameln 50 mg/ml koncentrat za otopinu za injekciju/infuziju
| Name | Amiodaronklorid hameln 50 mg/ml koncentrat za otopinu za injekciju/infuziju |
|---|---|
| Marketing Authorisation Number | HR-H-082154106 |
| Active Substance | amiodaronklorid |
| Composition | 1 ml koncentrata za otopinu za injekciju/infuziju sadrži 50 mg amiodaronklorida što odgovara 46,9 mg amiodarona |
| Pharmaceutical Form | Koncentrat za otopinu za injekciju / infuziju |
| Manufacturer | HBM Pharma s.r.o., Martin, Slovačka hameln rds s.r.o., Modra, Slovačka |
| Marketing Authorisation Holder | hameln pharma gmbH, Inselstrasse 1, Hameln, Njemačka |
| Marketing Authorisation Date | 29.11.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/22-02/95 |
| Registration Number | 381-12-01/70-22-03 |
| 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 | C01BD01 |
| Marketing status | stavljeno u promet |
| Shortage status | nema nestašice |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |