Iopromide Injectable Solution

Form: Injectable Solution

Strength: 300 mg/mL, 370 mg/mL

Reference Brands: Ultravist(US & EU)

Category: Contrast Agent

Iopromide injectable solution, marketed as Ultravist, is approved in the US by the FDA and in the EU via EMA for diagnostic imaging procedures, including angiography and CT scans. Regulatory approval requires comprehensive dossiers with clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews clinical trial and quality data for timely approval, while the EMA ensures regional safety and manufacturing compliance. 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, enabling high-quality imaging support for accurate diagnosis worldwide.