| Code | 4196E | ||||||||||
| MA number | EU/1/23/1743/002 | ||||||||||
| Product Form: | sus por 5x110ml/5 500 mg (fľ.HDPE+5 dávk.striek.+ 5 adaptérov) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU Orphan | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
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| Shelf life: | 24 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| 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: | 26.07.2023 |
| Validity: | 26.07.2028 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 21.09.2023 |
