{"entity":{"id":"gadoterate-meglumine","kind":"drug","name":"Gadoterate meglumine","aka":["gadoterate","gadoteric acid","Dotarem","Clariscan"],"tldr":"An MRI dye given into a vein for scans of the brain and spine, used for example to show brain tumours and metastases.","summary":"Guerbet's Dotarem (NDA 204781, first approved 20 March 2013) is indicated \"for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity\". GE Healthcare's Clariscan is an approved generic (ANDA 210016, 1 November 2019) with the same indication. ATC V08CA02 (gadoteric acid). Like every gadolinium-based contrast agent in the United States, its label carries a boxed warning on the risks of intrathecal use and nephrogenic systemic fibrosis, a thickening of skin and organs seen in people with severe kidney disease.","status":"approved","asOf":"2026-11-04","links":[{"label":"Drugs@FDA Dotarem (NDA 204781)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=204781"},{"label":"DailyMed label: Dotarem","url":"https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=82b83e61-6af8-4225-aa39-8cbf206f65b0"},{"label":"Drugs@FDA Clariscan (ANDA 210016)","url":"https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=210016"},{"label":"WHO ATC index V08CA: paramagnetic contrast media","url":"https://atcddd.fhi.no/atc_ddd_index/?code=V08CA&showdescription=no"}],"tags":["contrast-agents-gaps-2026-11","diagnostic"],"related":[],"cancers":["glioblastoma","secondary-brain-tumours"],"sections":[],"technologies":["gadolinium-based-contrast-agents","mri"],"targets":[],"drugs":[],"companies":["guerbet","ge-healthcare"],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"provenance":{"editedBy":"OnCo contrast agent gap fill (Drugs@FDA, FDA labels, DailyMed, EMA register, WHO ATC index)","editedOn":"2026-11-04"},"brand":"Dotarem","modality":"Gadolinium-based contrast agent for MRI of the brain and spine (intravenous)","mechanism":"A gadolinium chelate that brightens tissue on MRI where it leaves the blood, showing areas with a disrupted blood-brain barrier or abnormal vessels.","approvals":[{"region":"US","year":2013,"indication":"MRI of the brain, spine and associated tissues to visualise areas with disrupted blood-brain barrier or abnormal vascularity","note":"NDA 204781; Guerbet"}],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/gadoterate-meglumine/","neighbours":{"cancer":[{"id":"secondary-brain-tumours","kind":"cancer","name":"Brain metastases (secondary brain tumours)","route":"/cancers/secondary-brain-tumours/"},{"id":"glioblastoma","kind":"cancer","name":"Glioma & glioblastoma","route":"/cancers/glioblastoma/"}],"technology":[{"id":"gadolinium-based-contrast-agents","kind":"technology","name":"Gadolinium-based and other MRI contrast agents","route":"/technologies/gadolinium-based-contrast-agents/"},{"id":"mri","kind":"technology","name":"MRI","route":"/technologies/mri/"}],"company":[{"id":"ge-healthcare","kind":"company","name":"GE HealthCare","route":"/companies/ge-healthcare/"},{"id":"guerbet","kind":"company","name":"Guerbet","route":"/companies/guerbet/"}]}}