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 |