Loperamide – tablets/capsules

Form: Tablets/capsules

Strength: 2 mg

Reference Brands: Imodium(US & EU)

Category: Medical Aid

Loperamide tablets are approved in the EU and US for short-term relief of acute diarrhea. In the EU, brands like Imodium are regulated by EMA, supported by dossiers demonstrating safety, efficacy, and manufacturing standards. In the US, FDA approval relies on extensive clinical data, with generic formulations available. Both regions require detailed dossiers, including clinical trial results, quality assurance, and pharmacovigilance plans for approval and ongoing safety monitoring. Due to its widespread use, strict labeling, dosing, and safety guidelines are enforced. For regulatory support and dossier management, visit PharmaTradz. We facilitate seamless market access, ensuring adherence to European and US standards for safe, effective gastrointestinal therapy.