| Code | 7450D | ||||||||||
| MA number | EU/1/21/1530/007 | ||||||||||
| Product Form: | tbl flm 84x100 mg (blis.PVC/Al) | ||||||||||
| MA Status: | E - Valid centralised marketing authorisation | ||||||||||
| Type of procedure: | EU | ||||||||||
| MAH, country: | Angelini Pharma S.p.A, Italy | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 48 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 8(3) application - new active substance | 
| MA issued: | 26.03.2021 | 
| Validity: | 26.03.2026 | 
| SmPC + PL: |  | 
| Safety feature | Yes | 
| Data update: | 27.04.2021 |