Ledipasvir / sofosbuvir — Tablet (IR, oral)

المنتج المرجعي للتكافؤ الحيوي · Ledipasvir / sofosbuvir

Molecule	Ledipasvir / sofosbuvir
Dosage form	Tablet (IR, oral)
Reference comparator	Harvoni (Gilead)
Tier	A
Recommended BE approach	In vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A

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, Ledipasvir / sofosbuvir (Tablet (IR, oral)) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/ledipasvir-sofosbuvir-s215.html