Ioversol Injectable Solution

Form: Injectable Solution

Strength: 320 mg/mL, 350 mg/mL, 370 mg/mL

Reference Brands: Optiray(US & EU)

Category: Contrast Agent

Ioversol injectable solution, marketed as Optiray, is approved in the US by the FDA and in the EU via EMA for diagnostic imaging procedures like CT angiography and vascular imaging. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial data and quality documentation 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. Proper adherence to regional requirements supports swift approval, safe administration, and global availability, facilitating high-quality radiological diagnostics worldwide.