| Code | 1261F |
| MA number | EU/1/25/1969/001 |
| Product Form: | sol inj 1x0,8 mj/80 mg (pero napl.) |
| MA Status: | E - Valid centralised marketing authorisation |
| Type of procedure: | EU Orphan |
| MAH, country: | Swedish Orphan Biovitrum AB (publ), Sweden |
| Shelf life: | 48 |
| Container: | pre-filled pen |
| Route of admin.: | Subcutaneous use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 17.09.2025 |
| Validity: | 17.09.2030 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 26.09.2025 |
