Amiodaronklorid hameln 20 mg/ml otopina za infuziju
Name | Amiodaronklorid hameln 20 mg/ml otopina za infuziju |
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Marketing Authorisation Number | HR-H-475814519 |
Active Substance | amiodaronklorid |
Composition | jedan ml otopine sadrži 20 mg amiodaronklorida što odgovara 18,9 mg amiodarona. |
Pharmaceutical Form | otopina za infuziju |
Manufacturer | Solupharm Pharmazeutische Erzeugnisse GmbH, Melsungen, Njemačka hameln rds s.r.o., Modra, Slovačka |
Marketing Authorisation Holder | hameln pharma gmbH, Inselstrasse 1, Hameln, Njemačka |
Marketing Authorisation Date | 20.01.2021 |
MA Period of Validity | 20.01.2026 |
Classification Number | UP/I-530-09/19-01/232 |
Registration Number | 381-12-01/70-21-04 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | C01BD01 |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |