| 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 |
Medicinal product subject to medical prescription |
| Type of prescription |
Medicinal product subject to special medical prescription
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
N01AH01 |
| Marketing status |
Marketed |
| Shortage status |
No shortage |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
