| Code | 9689B | ||||||||||
| MA number | 21/0728/11-S | ||||||||||
| Product Form: | tbl flm 120x1000 mg (fľ.HDPE) | ||||||||||
| MA Status: | D - Marketing Authorisation valid for an unlimited period | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Sandoz Pharmaceuticals d.d., Slovenia | ||||||||||
| Therapeutic Class: | 21 - ANTIEPILEPTICA, ANTICONVULSIVA | ||||||||||
| ATC: | 
 | ||||||||||
| Shelf life: | 36 | ||||||||||
| Route of admin.: | Oral use | 
| Prescription Status: | Medicinal product subject to medical prescription. | 
| Legal basis: | Article 10(1) generic application | 
| MA issued: | 25.11.2011 | 
| Pediatric indication: | Yes | 
| Pediatric posology: | Yes | 
| Pediatric warnings: | Yes | 
| PIL: |  | 
| SPC: |  | 
| Safety feature | Yes | 
| Data update: | 09.05.2024 |