| Code | 9538C | ||||||||||
| MA number | EU/1/18/1302/001 | ||||||||||
| Product Form: | tbl sol 100x100 mg (fľ.HDPE) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | ORPHELIA Pharma SAS , France | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
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| Shelf life: | 48 | ||||||||||
| Container: | bottle HDPE | ||||||||||
| Route of admin.: | Oral or gastrointestinal use |
| Prescription Status: | Medicinal product subject to restricted medical prescription. |
| Legal basis: | Article 10(3) hybrid application |
| MA issued: | 20.09.2018 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 10.07.2023 |
