| Code | 9420C | ||||||||||
| MA number | 21/0341/18-S | ||||||||||
| Product Form: | tbl 50x400 mg (blis.PVC/Al-nepriehľad.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | G.L. Pharma GmbH, Austria | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: |
|
||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/Al | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 16.10.2018 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| PIL: |
PIL_Eslibon 08.2022.pdf
|
| SPC: |
SPC_Eslibon_08.2022.pdf
|
| Safety feature | Yes |
| Data update: | 26.01.2023 |
