| Code | 4946D | ||||||||||
| MA number | 57/0058/19-S | ||||||||||
| Product Form: | con inf 4x1000 µg (liek.inj.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 06.03.2019 |
| Validity: | 06.03.2024 |
| MA renewed: | Renewal application submitted |
| PIL: |
PIL_Dexmedetomidine Kalceks_11.2023.pdf
|
| SPC: |
SPC_Dexmedetomidine Kalceks_11.2023.pdf
|
| Safety feature | Yes |
| Data update: | 16.11.2023 |
