| Code | 2972D | ||||||||||
| MA number | 57/0375/19-S | ||||||||||
| Product Form: | con inf 25x2 ml (liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 29.11.2019 |
| SPC: |
SPC_Dexmedetomidine Viatris 100 mikrogramov_ml_con inf_07_2024.pdf
|
| PIL: |
PIL_Dexmedetomidine Viatris 100 mikrogramov_ml_con inf_07_2024.pdf
|
| Safety feature | Yes |
| Data update: | 09.07.2024 |
