Hydroxycarbamide (hydroxyurea) — Capsule (oral)

المنتج المرجعي للتكافؤ الحيوي · Hydroxycarbamide (hydroxyurea)

Molecule	Hydroxycarbamide (hydroxyurea)
Dosage form	Capsule (oral)
Reference comparator	Hydrea (BMS)
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, Hydroxycarbamide (hydroxyurea) (Capsule (oral)) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/hydroxycarbamide-hydroxyurea-s260.html