Amiodaronklorid hameln 50 mg/ml koncentrat za otopinu za injekciju/infuziju
Name | Amiodaronklorid hameln 50 mg/ml koncentrat za otopinu za injekciju/infuziju |
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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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | C01BD01 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |