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 |