| Code | 3538E | ||||||||||
| MA number | 65/0097/23-S | ||||||||||
| Product Form: | sol ijf 10x10 ml/500 µg (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | AS KALCEKS, Latvia | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | glass ampoule | ||||||||||
| Route of admin.: | Intravenous and epidural use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 16.05.2023 |
| Validity: | 16.05.2028 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Sufentanil Kalceks 5 mikrogramov-ml, 50 mikrogramov-ml injekčný-infúzny roztok_12.2023.pdf
|
| PIL: |
PIL_Sufentanil Kalceks 5 mikrogramov-ml, 50 mikrogramov-ml injekčný-infúzny roztok_12.2023.pdf
|
| Safety feature | Yes |
| Data update: | 26.05.2023 |
