Code | 75802 | ||||||||||
MA number | EU/1/09/514/004 | ||||||||||
Product Form: | tbl 7x400 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 |