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: |
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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 |