| Code | 5798C | ||||||||||
| MA number | 21/0342/17-S | ||||||||||
| Product Form: | tbl flm 168(3x56)x50 mg (blis.PVC/PVDC/Al-multibal.) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Viatris Limited, Ireland | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 36 | ||||||||||
| Container: | blister PVC/PVDC/Al | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 16.11.2017 | 
| Pediatric indication: | Yes | 
| Pediatric posology: | Yes | 
| SPC: |  | 
| PIL: |  | 
| Safety feature | Yes | 
| Data update: | 05.04.2022 |