Tacrolimus — Capsule (oral)

المنتج المرجعي للتكافؤ الحيوي · Tacrolimus

MoleculeTacrolimus
Dosage formCapsule (oral)
Reference comparatorPrograf (Astellas)
TierA
Recommended BE approachIn vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A
NoteNarrow 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.

Other entries for Tacrolimus

Prolonged-release capsule (oral) · Ointment (topical)

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Cite as: AUPAM Experts' Office, Tacrolimus (Capsule (oral)) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/tacrolimus-s267.html