| Code | 8494D | ||||
| MA number | EU/1/21/1539/001 | ||||
| Product Form: | dis inf 1x50 ml (250 ml, 100 ml) (vak EVA) | ||||
| MA Status: | Ex - Conditional centralised marketing authorisation | ||||
| Type of procedure: | EU Orphan | ||||
| ATC: |
|
||||
| Shelf life: | 12 | ||||
| Container: | bag ethylene vinyl acetate (EVA) | ||||
| 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: | 18.08.2021 |
| Validity: | 19.08.2023 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | No |
| Data update: | 04.07.2022 |
