| Name |
Palonozetron Kalceks 250 mikrograma otopina za injekciju |
| Marketing Authorisation Number |
HR-H-535362574 |
| Active Substance |
palonozetronklorid |
| Composition |
jedan ml otopine sadrži 50 mikrograma palonozetrona (u obliku palonozetronklorida) jedna bočica otopine od 5 ml sadrži 250 mikrograma palonozetrona (u obliku palonozetronklorida) |
| Pharmaceutical Form |
otopina za injekciju |
| Manufacturer |
AS Kalceks, Riga, Latvija |
| Marketing Authorisation Holder |
AS Kalceks, Krustpils iela 71E, Riga, Latvija |
| Marketing Authorisation Date |
17.11.2021 |
| MA Period of Validity |
17.11.2026 |
| Classification Number |
UP/I-530-09/20-01/245 |
| Registration Number |
381-12-01/70-21-04 |
| Prescription |
Medicinal product subject to medical prescription |
| Type of prescription |
ograničeni recept
|
| Distribution |
Supply through pharmacies (community) |
| Advertising to general public |
not allowed |
| ATC Code |
A04AA05 |
| Marketing status |
stavljeno u promet |
| Shortage status |
nema nestašice |
| SmPC |
download |
| PL |
download |
| Public Assessment Report |
download
|
| Summary of risk management plan |
download |
