
Gadoversetamide Injectable Solution
Form: Injectable Solution
Strength: 0.5 mol/L
Reference Brands: OptiMARK(US & EU)
Category: Contrast Agent
Gadoversetamide, marketed as OptiMARK, is approved in the US by the FDA and in the EU through EMA for MRI contrast enhancement. Regulatory approval requires comprehensive dossiers including 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 regulations supports swift approval, safe administration, and global availability, enabling high-quality diagnostic imaging, supporting neurological, cardiovascular, and musculoskeletal assessments worldwide.
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 EnquiryBarium Sulfate Suspension
Strength: 30% w/v , 40% w/v
Form: Powder for oral suspension
Reference Brands: Gastroview, Osmo-Maq, FlexiView(US)
View Details Get EnquiryGadoxetate Injectable Solution
Strength: 0.25 mmol/mL
Form: Injectable Solution
Reference Brands: Eovist(US)
View Details Get EnquiryGadofosveset Injectable solution
Strength: 0.03 mmol/kg
Form: Injectable Solution
Reference Brands: Ablivar(US & EU)
View Details Get Enquiry