| Code | 5214E |
| MA number | EU/1/23/1776/001 |
| Product Form: | sus por 1x100 ml/4 000 mg (fľ.skl.jantár.+adaptér+2 per.striek.) |
| MA Status: | E - Valid centralised marketing authorisation |
| Type of procedure: | EU Orphan |
| MAH, country: | Santhera Pharmaceuticals (Deutschland) GmbH , Germany |
| Shelf life: | 24 |
| Container: | amber glass bottle |
| 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: | 14.12.2023 |
| Validity: | 14.12.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 03.01.2024 |
