| Code | 2866F | ||||||||||
| MA number | 21/0067/26-S | ||||||||||
| Product Form: | tbl flm 56x10 mg (blis.Al/PVC/PVDC) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 24 | ||||||||||
| Container: | blister Al/PVC/PVDC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 17.03.2026 |
| Validity: | 17.03.2031 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Abavalex filmom obalené tablety_tbl flm_03/2026_REG.pdf
|
| PIL: |
PIL_Abavalex filmom obalené tablety_tbl flm_03/2026_REG.pdf
|
| Safety feature | Yes |
| Data update: | 20.03.2026 |
