| Code | 2550D | ||||||||||
| MA number | EU/1/19/1389/001 | ||||||||||
| Product Form: | sol por 1x100 ml/10 g (fľ.skl.jantár.) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| MAH, country: | Jazz Pharmaceuticals Ireland Ltd, Ireland | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
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| 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 - known active substance |
| MA issued: | 19.09.2019 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 09.01.2025 |
