| Code | 5390C | ||||||||||
| MA number | EU/1/09/514/025 | ||||||||||
| Product Form: | tbl 180 (2x90)x800 mg (blis.PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | BIAL-Portela & Ca, SA, Portugal | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
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| Shelf life: | 60 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 8(3) application - new active substance |
| MA issued: | 21.04.2009 |
| SmPC + PL: |
European Medicines Agency's database
|
| Safety feature | Yes |
| Data update: | 21.06.2018 |
