Sugamadeks AptaPharma 100 mg/ml otopina za injekciju
| Name | Sugamadeks AptaPharma 100 mg/ml otopina za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-033314955 |
| Active Substance | sugamadeksnatrij |
| Composition | 1 ml otopine sadrži 100 mg sugamadeksa (u obliku sugamadeksnatrija) |
| Pharmaceutical Form | otopina za injekciju |
| Manufacturer | Laboratorios Normon S.A., Tres Cantos – Madrid, Španjolska |
| Marketing Authorisation Holder | Apta Medica Internacional d.o.o., Likozarjeva ulica 6, Ljubljana, Slovenija |
| Marketing Authorisation Date | 16.06.2023 |
| MA Period of Validity | 16.06.2028 |
| Classification Number | UP/I-530-09/22-01/29 |
| Registration Number | 381-12-01/70-23-09 |
| Prescription | na recept |
| Type of prescription | ograničeni recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | V03AB35 |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
