Valproate sodium / valproic acid — Gastro-resistant / MR tablet (oral)

المنتج المرجعي للتكافؤ الحيوي · Valproate sodium / valproic acid

Molecule	Valproate sodium / valproic acid
Dosage form	Gastro-resistant / MR tablet (oral)
Reference comparator	Depakine / Epilim (Sanofi)
Tier	A
Recommended BE approach	In vivo bioequivalence (PK; fasting + fed; multiple-dose where required)
Note	Narrow therapeutic index

Illustrative harmonised register entry for the Arab markets. Confirm the definitive comparator with the authority of each market before use.
سجل استرشادي موحد · يلزم تأكيد المقارن النهائي من سلطة كل سوق قبل الاستخدام.

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Cite as: AUPAM Experts' Office, Valproate sodium / valproic acid (Gastro-resistant / MR tablet (oral)) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/valproate-sodium-valproic-acid-s135.html