| Code | 2804F | ||||||||||
| MA number | 01/0061/26-S | ||||||||||
| Product Form: | sol inj 50x1,8 ml (náplň skl.s piestom na manuál.aspiráciu) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Mutual recognition procedure | ||||||||||
| MAH, country: | Laboratorios Inibsa, S.A., Spain | ||||||||||
| Therapeutic Class: | 01 - ANAESTHETICA (LOKÁLNE) | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | glass cartrige | ||||||||||
| Route of admin.: | Infiltration and perineural use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 14.03.2026 |
| Validity: | 14.03.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_SYLANEST 40 mg/ml + 5 mikrogramov/ml injekčný roztok_sol inj_02/2026_REG.pdf
|
| SPC: |
SPC_SYLANEST 40 mg/ml + 5 mikrogramov/ml injekčný roztok_sol inj_02/2026_REG.pdf
|
| Safety feature | Yes |
| Data update: | 19.03.2026 |
