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 |
| 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 |
|---|---|---|
| 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. |
