Ciclosporin — Capsule (oral, microemulsion)

المنتج المرجعي للتكافؤ الحيوي · Ciclosporin

MoleculeCiclosporin
Dosage formCapsule (oral, microemulsion)
Reference comparatorNeoral / Sandimmun (Novartis)
TierA
Recommended BE approachIn vivo bioequivalence (PK; single-dose fasting, fed if required) — ICH M13A
NoteNarrow therapeutic index; microemulsion
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 Ciclosporin

Eye drops, emulsion

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Cite as: AUPAM Experts' Office, Ciclosporin (Capsule (oral, microemulsion)) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/ciclosporin-s269.html