Iomeprol Injectable Solution

Form: Injectable Solution

Strength: 350 mg/mL and 400 mg/mL

Reference Brands: Iomeron(US & EU)

Category: Contrast Agent

Iomeprol injectable solution, marketed as Iomeron, is approved in the US by the FDA and in the EU via EMA for contrast-enhanced imaging procedures including CT angiography and vascular imaging. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality information to ensure safety and effectiveness, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports timely approval, safe administration, and worldwide availability, supporting high-quality diagnostic imaging globally.