| Code | 8014D | ||||||||
| MA number | EU/1/21/1551/002 | ||||||||
| Product Form: | con inf 1x8 ml/1200 mg (liek.inj.skl.) | ||||||||
| MA Status: | Ev - Valid centralised marketing authorisation under exceptional circumstances | ||||||||
| Type of procedure: | EU | ||||||||
| MAH, country: | Ultragenyx Germany GmbH, Germany | ||||||||
| ATC: |
|
||||||||
| Shelf life: | 36 | ||||||||
| Container: | glass vial | ||||||||
| 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: | 17.06.2021 |
| Validity: | 17.06.2026 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 26.04.2022 |
