| Code | 1516E | ||||||||||
| MA number | 21/0196/22-S | ||||||||||
| Product Form: | tbl 196 (2x98)x300 mg (blis.PVC/Al) - multibal.) | ||||||||||
| MA Status: | R - Valid Marketing Authorisation | ||||||||||
| Type of procedure: | Decentralised | ||||||||||
| MAH, country: | Neuraxpharm Bohemia s.r.o., Czechia | ||||||||||
| 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(3) hybrid application |
| MA issued: | 30.07.2022 |
| Validity: | 30.07.2027 |
| Pediatric indication: | Yes |
| Pediatric posology: | Yes |
| Pediatric warnings: | Yes |
| PIL: |
PIL_Zonisamide Neuraxpharm tbl_10.2023.pdf
|
| SPC: |
SPC_Zonisamide Neuraxpharm tbl_06.2024.pdf
|
| Safety feature | Unknown |
| Data update: | 31.05.2024 |
