Otilonium Bromide tablets

Form: Tablets

Strength: 40 mg

Reference Brands: Spasmomen(EU)

Category: Gastrointestinal Drugs

Otilonium bromide tablets, marketed as Spasmomen, are approved in the EU for irritable bowel syndrome (IBS) and colonic spasms, with regional dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, it is not widely marketed and mainly available as a generic or compounded product. Regulatory approval in the EU ensures regional safety and efficacy compliance, supporting gastrointestinal symptom management. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional adherence supports timely approval, safe use, and broad availability, helping patients worldwide manage gastrointestinal motility disorders effectively across regions.