
Gadoterate Meglumine Injectable Solution
Form: Injectable Solution
Strength: 0.5 mol/L
Reference Brands: Dotarem(US & EU)
Category: Contrast Agent
Gadoterate meglumine, marketed as Dotarem, is approved in the US by the FDA and in the EU via EMA for MRI diagnostics of brain, spinal cord, and joints. 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 and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports swift approval, safe administration, and global availability, assisting healthcare providers worldwide in delivering high-quality diagnostic imaging.
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