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 |