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 |
| MA Revocation Date | 24.09.2025* |
| 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 | trajni prekid opskrbe |
| SmPC | download |
| PL | download |
| Public Assessment Report | download |
| Summary of risk management plan | download |
*Note
Marketing authorisation has been revoked by request of the marketing authorisation holder. In accordance with Article 113 of Medicinal Products Act (Official Gazette No. 76/13), only a medicinal product in respect of which a marketing authorisation has been granted by the Agency for Medicinal Products and Medical Devices or the European Commision, and a medicinal product in respect of which an authorisation for parallel import or parallel distribution has been granted may be placed on the market of the Republic of Croatia. By way of derogation from this provision, a batch of medicinal product may be on the market for no longer than 18 months following the expiry of revocation of the marketing authorisation, unless its shelf life expires first.
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. |
