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PRODUCT DETAIL

Zonisamide Neuraxpharm 50 mg tablety

Code 1490E
MA number 21/0193/22-S
Product Form: tbl 14x50 mg (blis.PVC/Al)
MA Status: R - Valid Marketing Authorisation
Type of procedure: Decentralised
MAH, country: Neuraxpharm Bohemia s.r.o., Czechia
Therapeutic Class: 21 - ANTIEPILEPTICA, ANTICONVULSIVA
ATC:
N NERVOUS SYSTEM
N03 ANTIEPILEPTICS
N03A ANTIEPILEPTICS
N03AX Other antiepileptics
N03AX15 Zonisamide
Shelf life: 36
Container: blister PVC/Al
Route of admin.: Oral use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 10(1) generic 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
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