Medicinal Products

Deksmedetomidin Kabi 100 mikrograma/ml koncentrat za otopinu za infuziju

Name Deksmedetomidin Kabi 100 mikrograma/ml koncentrat za otopinu za infuziju
Marketing Authorisation Number HR-H-989230458
Active Substance deksmedetomidinklorid
Composition svaki ml koncentrata sadrži 100 mikrograma deksmedetomidina u obliku deksmedetomidinklorida
Pharmaceutical Form Koncentrat za otopinu za infuziju
Manufacturer Fresenius Kabi Austria GmbH, Graz, Austrija
Marketing Authorisation Holder Fresenius Kabi d.o.o., Radnička cesta 37a, Zagreb, Hrvatska
Marketing Authorisation Date 03.09.2021
MA Period of Validity 03.09.2026
Classification Number UP/I-530-09/20-01/218
Registration Number 381-12-01/14-21-04
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 N05CM18
Marketing status stavljeno u promet
Shortage status u tijeku
SmPC download
PL download
Public Assessment Report download

Packaging

Direct Healthcare Professional Communication

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Pismo zdravstvenim radnicima o povećanom riziku od smrtnosti u bolesnika u dobi 65 godina i mlađih, vezano uz primjenu lijekova koji sadrže deksmedetomidin na jedinicama intenzivnog liječenja 15.06.2022 EVER Valinject GmbH, AS Kalceks, Mylan Ireland Limited, Pliva Hrvatska d.o.o., Orion Corporation, Accord Healthcare S.L.U.
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