| 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 |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to restricted medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
V08CA02 |
| Marketing status |
Never marketed |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
