| Code | 0608F | ||||||||||
| MA number | 39/0248/25-S | ||||||||||
| Product Form: | sol inf 20x500 ml (vak PP/PA/PE) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Vantive Belgium SRL, Belgium | ||||||||||
| Therapeutic Class: | 39 - SOLI A IONTY PRO P.O. A PARENT. APLIKÁCIU | ||||||||||
| ATC: |
|
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| Shelf life: | 12 | ||||||||||
| Container: | bag PP/PA/PE | ||||||||||
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10a well-established use application |
| MA issued: | 19.08.2025 |
| Validity: | 19.08.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric contraindication: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Icalziss 340 mmol/l infúzny roztok_sol inf_07/2025_REG.pdf
|
| PIL: |
PIL_Icalziss 340 mmol/l infúzny roztok_sol inf_07/2025_REG.pdf
|
| Safety feature | No |
| Data update: | 26.08.2025 |
