| Code | 2013F | ||||||||||
| MA number | 21/0411/25-S | ||||||||||
| Product Form: | cps dur 100x400 mg (fľ.HDPE) | ||||||||||
| 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 | ||||||||||
| Route of admin.: | Oral use |
| Prescription Status: | Medicinal product subject to medical prescription. |
| Legal basis: | Article 10(1) generic application |
| MA issued: | 28.11.2025 |
| Validity: | 28.11.2030 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Gasenlan_11.2025.pdf
|
| SPC: |
SPC_Gasenlan_11.2025.pdf
|
| Safety feature | Yes |
| Data update: | 03.12.2025 |
