Tacrolimus — Prolonged-release capsule (oral)

المنتج المرجعي للتكافؤ الحيوي · Tacrolimus

MoleculeTacrolimus
Dosage formProlonged-release capsule (oral)
Reference comparatorAdvagraf / Astagraf XL (Astellas)
TierA
Recommended BE approachIn vivo bioequivalence (PK; fasting + fed; multiple-dose where required)
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

Capsule (oral) · Ointment (topical)

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Cite as: AUPAM Experts' Office, Tacrolimus (Prolonged-release capsule (oral)) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/tacrolimus-s268.html