Deksmedetomidin Mylan 100 mikrograma/ml koncentrat za otopinu za infuziju
Name | Deksmedetomidin Mylan 100 mikrograma/ml koncentrat za otopinu za infuziju |
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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 |
Packaging [MA Number for Packaging] | 5 bočica s 2 ml koncentrata, u kutiji [HR-H-501960991-01] 25 bočica s 2 ml koncentrata, u kutiji [HR-H-501960991-02] |
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 |
Direct Healthcare Professional Communication
Name | Date | Download |
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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. |