Gadoxetate Injectable Solution

Form: Injectable Solution

Strength: 0.25 mmol/mL

Reference Brands: Eovist(US)

Category: Contrast Agent

Gadoxetate, marketed as Primovist in the EU and Eovist in the US, is approved for liver MRI by the EMA and FDA for hepatobiliary imaging. Regulatory approval requires a detailed dossier, including clinical efficacy, safety profiles, 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 supports swift approval, safe administration, and worldwide availability, supporting early diagnosis and optimal management of liver diseases across healthcare regions globally.