| Code | 6513E | ||||||||||
| MA number | EU/1/23/1783/001 | ||||||||||
| Product Form: | sol inj 1x15 ml/100 mg (liek.inj.skl.) | ||||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Biogen Netherlands B.V., Netherland | ||||||||||
| Therapeutic Class: | 87 - VARIA I | ||||||||||
| ATC: |
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| Shelf life: | 42 | ||||||||||
| Container: | glass vial | ||||||||||
| Route of admin.: | Intrathecal use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 29.05.2024 |
| Validity: | 29.05.2029 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 24.10.2025 |
