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PRODUCT DETAIL

Depakine 400 mg/4 ml

Code 84386
MA number 21/0674/96-S
Product Form: plv iol 4x400 mg+4x4 ml solv. (liek.inj.skl.+amp.skl.)
MA Status: D - Marketing Authorisation valid for an unlimited period
Type of procedure: National
Therapeutic Class: 21 - ANTIEPILEPTICA, ANTICONVULSIVA
ATC:
N NERVOUS SYSTEM
N03 ANTIEPILEPTICS
N03A ANTIEPILEPTICS
N03AG Fatty acid derivatives
N03AG01 Valproic acid
Shelf life: 36
Container: glass vial
Route of admin.: Intravenous use
Prescription Status: Medicinal product subject to medical prescription.
Legal basis: Article 8(3) application - new active substance
MA issued: 27.08.1996
Pediatric warnings: Yes
Dokument: DHPC_valproate 22 12 2014.pdf  
PIL: PIL_Depakine_plv iol_06.2023.pdf  
SPC: SPC_Depakine_plv iol_12.2023.pdf  
Dokument: DHPC_Valproát_19.02.2024.pdf  
Safety feature Yes
Data update: 17.04.2018
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