Palonozetron Kalceks 250 mikrograma otopina za injekciju
Name | Palonozetron Kalceks 250 mikrograma otopina za injekciju |
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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 | na recept |
Type of prescription | ograničeni recept |
Distribution | u ljekarni |
Advertising to general public | zabranjeno |
ATC Code | A04AA05 |
Medicinal product marketed in the Croatia | Da |
SmPC | download |
PL | download |
Public Assessment Report | download |
Summary of risk management plan | download |