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
Packaging description
MA Number for Packaging
Marketing status
Shortage status
5 bočica s 2 ml koncentrata, u kutiji
HR-H-501960991-01
-
-
25 bočica s 2 ml koncentrata, u kutiji
HR-H-501960991-02
privremeni prekid opskrbe
-
Direct Healthcare Professional Communication
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