Medicinal Products
Deksmedetomidin Mylan 100 mikrograma/ml koncentrat za otopinu za infuziju
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
Mylan Ireland Limited, Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Irska
Marketing Authorisation Date
23.02.2023
MA Period of Validity
unlimited
Classification Number
UP/I-530-09/22-02/197
Registration Number
381-12-01/70-23-05
Prescription
na recept
Type of prescription
ograničeni recept
Distribution
u ljekarni
Advertising to general public
zabranjeno
ATC Code
N05CM18
Medicinal product marketed in the Croatia
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
Back