Cyclolux 0,5 mmol/ml otopina za injekciju
| Name | Cyclolux 0,5 mmol/ml otopina za injekciju |
|---|---|
| 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 |
