| Code | 2265F | ||||||||||
| MA number | 21/0431/25-S | ||||||||||
| Product Form: | tbl flm 168 (3x56)x50 mg (blis.Al/OPA/Al/PVC - multibal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Egis Pharmaceuticals PLC, Hungary | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 06.01.2026 |
| Validity: | 06.01.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Breluncol _12.2025.pdf
|
| SPC: |
SPC_Breluncol _12.2025.pdf
|
| Safety feature | Yes |
| Data update: | 07.01.2026 |
