Sugamadeks Qilu 100 mg/ml otopina za injekciju
| Name | Sugamadeks Qilu 100 mg/ml otopina za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-574668052 |
| Active Substance | sugamadeksnatrij |
| Composition | 1 ml otopine sadrži 100 mg sugamadeksa (u obliku sugamadeksnatrija) |
| Pharmaceutical Form | otopina za injekciju |
| Manufacturer | Kymos S.L., Cerdanyola del Valles, Barcelona, Španjolska
Eurofins Analytical Services Hungary Kft., Budimpešta, Mađarska |
| Marketing Authorisation Holder | Qilu Pharma Spain S.L., Paseo de la Castellana 40, planta 8, Madrid, Španjolska |
| Marketing Authorisation Date | 26.10.2022 |
| MA Period of Validity | 26.10.2027 |
| Classification Number | UP/I-530-09/21-01/182 |
| Registration Number | 381-12-01/70-22-08 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | V03AB35 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
