| Code | 8425D | ||||||||||
| MA number | 57/0222/21-S | ||||||||||
| Product Form: | con inf 1x4 ml (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Fresenius Kabi s.r.o., Czechia | ||||||||||
| 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: | 20.08.2021 |
| Validity: | 20.08.2026 |
| MA renewed: | Renewal application submitted |
| SPC: |
SPC_Dexmedetomidine Kabi 100 mikrogramov ml_11.2022.pdf
|
| PIL: |
PIL_Dexmedetomidine Kabi 100 mikrogramov ml_11.2022.pdf
|
| Safety feature | Yes |
| Data update: | 30.08.2021 |
