Iopamidol Injectable Solution

Form: Injectable Solution

Strength: 37%, 61%, 76%, and 78%

Reference Brands: Isovue(US), Iopamiro(EU)

Category: Contrast Agent

Iopamidol injectable solution, marketed as Isovue in the US and Iopamiro in the EU, is approved for use as a contrast agent in X-ray and CT imaging. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality data, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional requirements supports timely approval, safe use, and worldwide availability, facilitating high-quality diagnostic imaging in healthcare systems globally.