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PRODUCT DETAIL

Sufentanil Kalceks 50 mikrogramov/ml injekčný/infúzny roztok

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:
N NERVOUS SYSTEM
N01 ANESTHETICS
N01A ANESTHETICS, GENERAL
N01AH Opioid anesthetics
N01AH03 Sufentanil
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
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