Iohexol Injectable Solution

Form: Injectable Solution

Strength: 240 mg/mL, 300 mg/mL, 350 mg/mL, 140 mg/mL

Reference Brands: Omnipaque(US & EU)

Category: Contrast Agent

Iohexol injectable solution, marketed as Omnipaque, is approved in the US by the FDA and in the EU via EMA for use as a contrast agent in diagnostic imaging. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety, efficacy, and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence supports swift approval, safe administration, and broad global availability, enabling precise imaging for effective diagnosis and treatment planning worldwide.