Fentanil Kalceks 50 mikrograma/ml otopina za injekciju
| Name | Fentanil Kalceks 50 mikrograma/ml otopina za injekciju |
|---|---|
| Marketing Authorisation Number | HR-H-156092195 |
| Active Substance | fentanilcitrat |
| Composition | jedan ml otopine sadrži 50 mikrograma fentanila (u obliku fentanilcitrata) jedna ampula od 2 ml sadrži 100 mikrograma fentanila (u obliku fentanilcitrata) jedna ampula od 10 ml sadrži 500 mikrograma fentanila (u obliku fentanilcitrata) |
| Pharmaceutical Form | otopina za injekciju |
| Manufacturer | AS Kalceks, Riga, Latvija |
| Marketing Authorisation Holder | AS Kalceks, Krustpils iela 71E, Riga, Latvija |
| Marketing Authorisation Date | 11.01.2022 |
| MA Period of Validity | unlimited |
| Classification Number | UP/I-530-09/21-02/164 |
| Registration Number | 381-12-01/70-22-03 |
| Prescription | na recept |
| Type of prescription | poseban recept |
| Distribution | u ljekarni |
| Advertising to general public | zabranjeno |
| ATC Code | N01AH01 |
| Medicinal product marketed in the Croatia | Da |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
