| Code | 9355E | ||||||||||
| MA number | 21/0085/25-S | ||||||||||
| Product Form: | tbl flm 50x1000 mg (blis. Al/PVC) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Shelterpharma S.L., Spain | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 48 | ||||||||||
| Container: | blister Al/PVC | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.03.2025 |
| Validity: | 28.03.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| SPC: |
SPC_Levetiracetam Shelterpharma 1000 mg filmom obalené tablety_tbl flm_03/2025_REG.pdf
|
| PIL: |
PIL_Levetiracetam Shelterpharma 1000 mg filmom obalené tablety_tbl flm_03/2025_REG.pdf
|
| Safety feature | Yes |
| Data update: | 11.04.2025 |
