| Code | 2364F |
| MA number | EU/1/25/1974/001 |
| Product Form: | tbl flm 28x400 mg (blis.PVC/PCTFE/Al) |
| MA Status: | E - Valid centralised marketing authorisation |
| Type of procedure: | EU Orphan |
| MAH, country: | Sanofi B.V., Netherland |
| Shelf life: | 36 |
| Container: | blister PVC/PCTFE/Al |
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 22.12.2025 |
| Validity: | 22.12.2030 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 29.12.2025 |
