| Code | 2408F |
| MA number | EU/1/25/1996/001 |
| Product Form: | dis inf 1x50 ml (vak EVA) |
| MA Status: | E - Valid centralised marketing authorisation |
| Type of procedure: | EU Orphan |
| MAH, country: | Fondazione Telethon ETS, Italy |
| Shelf life: | 6 |
| Container: | bag ethylene vinyl acetate (EVA) |
| Route of admin.: | Intravenous use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 09.01.2026 |
| Validity: | 09.01.2031 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | No |
| Data update: | 22.01.2026 |
