| Code | 5446E |
| MA number | EU/1/23/1786/001 |
| Product Form: | cps dur 90x50 mg (fľ.HDPE) |
| MA Status: | E - Valid centralised marketing authorisation |
| Type of procedure: | EU Orphan |
| MAH, country: | Biogen Netherlands B.V., Netherland |
| Shelf life: | 48 |
| Container: | bottle HDPE |
| 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: | 09.02.2024 |
| Validity: | 09.02.2029 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 13.02.2024 |
