| Code | 9309E | ||||||||||
| MA number | 65/0066/25-S | ||||||||||
| Product Form: | emp tdm 8x50 mikrogramov/h (vre.PET/Al/PE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 65 - ANALGETICA - ANODYNA | ||||||||||
| ATC: |
|
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| Shelf life: | 24 | ||||||||||
| Container: | sachet PET/Al/PE | ||||||||||
| Route of admin.: | Transdermal use |
| Prescription Status: | Medicinal product subject to special medical prescription with skew blue stripe. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 26.03.2025 |
| Validity: | 26.03.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Fentanyl Sandoz d.d._03.2025.pdf
|
| SPC: |
SPC_Fentanyl Sandoz d.d._03.2025.pdf
|
| Safety feature | Yes |
| Data update: | 02.04.2025 |
