| Code | 8338C | ||||||||||
| MA number | 57/0207/18-S | ||||||||||
| Product Form: | con inf 4x4 ml (liek.inj.skl.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | EVER Valinject GmbH, Austria | ||||||||||
| Therapeutic Class: | 57 - HYPNOTICA, SEDATIVA | ||||||||||
| ATC: |
|
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| Shelf life: | 48 | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 28.06.2018 |
| SPC: |
SPC_Dexmedetomidine EVER Pharma_10.2023.pdf
|
| PIL: |
PIL_Dexmedetomidine EVER Pharma 100 mikrogramov-ml koncentrát na infúzny roztok_10.2023.pdf
|
| Safety feature | Yes |
| Data update: | 10.10.2023 |
