Ioversol Injectable Solution

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.

Get Enquiry Back to Listing
Disclaimer: By continuing to browse, you agree to the terms of use of this website and the Trade Marks displayed, in compliance with the provisions of the Trademark Act, 1999, Section 30 and 30(1) under 'Fair use.'

The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.

Related Products

Sulfur Hexafluoride Microbubbles injection

Strength: 60.7mg

Form: injection

Reference Brands: SonoVue(EU)

View Details Get Enquiry
Barium Sulfate Suspension

Strength: 30% w/v , 40% w/v

Form: Powder for oral suspension

Reference Brands: Gastroview, Osmo-Maq, FlexiView(US)

View Details Get Enquiry
Gadoxetate Injectable Solution

Strength: 0.25 mmol/mL

Form: Injectable Solution

Reference Brands: Eovist(US)

View Details Get Enquiry
Gadofosveset Injectable solution

Strength: 0.03 mmol/kg

Form: Injectable Solution

Reference Brands: Ablivar(US & EU)

View Details Get Enquiry

Subscribe to Our Newsletter

Stay updated on pharma trends and marketplace opportunities.