| Code | 0324D | ||||||||||
| MA number | 65/0020/19-S | ||||||||||
| Product Form: | sol ijf 5x10 ml (amp.skl.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| 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 |
