Medicinal Products

Deksmedetomidin Viatris 100 mikrograma/ml koncentrat za otopinu za infuziju

Name Deksmedetomidin Viatris 100 mikrograma/ml koncentrat za otopinu za infuziju
Former Name Deksmedetomidin Mylan 100 mikrograma/ml koncentrat za otopinu za infuziju
Marketing Authorisation Number HR-H-501960991
Active Substance deksmedetomidinklorid
Composition jedan ml koncentrata sadrži deksmedetomidinklorid u količini koja odgovara 100 mikrograma deksmedetomidina
Pharmaceutical Form koncentrat za otopinu za infuziju
Manufacturer Mylan Teoranta, Co. Galway, Irska
Marketing Authorisation Holder Viatris Limited, Damastown Industrial Park, Mulhuddart, Dublin, Irska
Marketing Authorisation Date 01.07.2024
MA Period of Validity unlimited
Classification Number UP/I-530-09/22-02/197
Registration Number 381-12-01/171-24-14
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 privremeni prekid opskrbe
SmPC download
PL download
Public Assessment Report download
Summary of risk management plan download

Packaging

Direct Healthcare Professional Communication

Name Date Download
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.
Back