Mesalazine (mesalamine) — Gastro-resistant / MR tablet (oral)

المنتج المرجعي للتكافؤ الحيوي · Mesalazine (mesalamine)

MoleculeMesalazine (mesalamine)
Dosage formGastro-resistant / MR tablet (oral)
Reference comparatorPentasa / Asacol (Ferring/Tillotts)
TierA
Recommended BE approachIn vivo bioequivalence (PK; fasting + fed; multiple-dose where required)
NoteLocally acting GI
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, Mesalazine (mesalamine) (Gastro-resistant / MR tablet (oral)) — bioequivalence reference product — AUPAM Register, retrieved 2026-08-31, https://aupameo.org/datasets/register/mesalazine-mesalamine-s106.html