Cyclolux 0,5 mmol/ml otopina za injekciju
Name | Cyclolux 0,5 mmol/ml otopina za injekciju |
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Marketing Authorisation Number | HR-H-062832318 |
Active Substance | meglumingadoterat |
Composition | jedan ml otopine sadrži 279,32 mg gadoteratne kiseline u obliku megluminske soli, što odgovara 0,5 mmol/ml gadoteratne kiseline |
Pharmaceutical Form | otopina za injekciju |
Manufacturer | Sanochemia Pharmazeutika GmbH, Neufeld An Der Leitha, Austrija |
Marketing Authorisation Holder | Sanochemia Pharmazeutika GmbH, Landegger-Strasse 7, Neufeld An Der Leitha, Austrija |
Marketing Authorisation Date | 16.12.2022 |
MA Period of Validity | 16.12.2027 |
Classification Number | UP/I-530-09/21-01/333 |
Registration Number | 381-12-01/154-22-10 |
Prescription | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | V08CA02 |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |