Iodixanol Injectable Solution

Form: Injectable Solution

Strength: 270 mg/mL, 320 mg/mL, 370 mg/mL

Reference Brands: Visipaque(US & EU)

Category: Contrast Agent

Iodixanol, marketed as Visipaque, is approved in the US by the FDA and in the EU via EMA for use as a contrast agent in X-ray and CT imaging procedures. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Supporting regional adherence supports swift approval, safe administration, and global availability of iodixanol, facilitating effective diagnostics worldwide.