Code | 0325D | ||||||||||
MA number | 65/0020/19-S | ||||||||||
Product Form: | sol ijf 10x10 ml (amp.skl.) | ||||||||||
MA Status: | R - Valid Marketing Authorisation | ||||||||||
Type of procedure: | Decentralised | ||||||||||
MAH, country: | MEDOCHEMIE Ltd., Cyprus | ||||||||||
Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
ATC: |
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Shelf life: | 30 | ||||||||||
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: | 30.01.2019 |
Validity: | 30.01.2024 |
MA renewed: | Renewal application submitted |
Pediatric indication: | Yes |
Pediatric posology: | Yes |
Pediatric contraindication: | Yes |
Pediatric warnings: | Yes |
SPC: | SPC_SOFENTIL injekčný-infúzny roztok_03.2024.pdf |
PIL: | PIL_SOFENTIL injekčný-infúzny roztok_03.2024.pdf |
Safety feature | Yes |
Data update: | 05.02.2019 |