| Code | 5599D | ||||||||||
| MA number | 57/0214/20-S | ||||||||||
| Product Form: | con inf 10x2 ml (amp.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | B.Braun Melsungen AG, Germany | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 29.09.2020 |
| SPC: |
SPC_Dexmedetomidine B. Braun_12.2024.pdf
|
| PIL: |
PIL_Dexmedetomidine B. Braun_12.2024.pdf
|
| Safety feature | Yes |
| Data update: | 22.04.2025 |
