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A widely used MRI dye given into a vein. Its American licence includes brain and spine scans and breast MRI to see how far a breast cancer extends.
The FDA label (Bayer, NDA 201277, first approved 14 March 2011) covers MRI of the central nervous system "to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity", MRI of the breast "to assess the presence and extent of malignant breast disease in adult patients", MR angiography and cardiac MRI. A generic gadobutrol, GE Healthcare's Pixxoscan, was approved under ANDA 215957 on 29 June 2026. ATC V08CA09. 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.
A gadolinium chelate that shortens proton relaxation times, so tissues where it leaks out of blood vessels, such as tumours with a disrupted blood-brain barrier or abnormal vessels, appear bright on MRI.
| Region | Year | Indication |
|---|---|---|
| US | 2011 | MRI of the central nervous system; breast MRI to assess the presence and extent of malignant breast disease; MR angiography; cardiac MRI · NDA 201277; Bayer |
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Query for this drug: (TITLE:"Gadobutrol" OR ABSTRACT:"Gadobutrol" OR TITLE:"Gadavist" OR ABSTRACT:"Gadavist" OR TITLE:"gadobutrol" OR ABSTRACT:"gadobutrol" OR TITLE:"Pixxoscan" OR ABSTRACT:"Pixxoscan") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Gadobutrol, not a curated reading list.
Shares Gadolinium-based and other MRI contrast agents, Bayer, Brain metastases (secondary brain tumours), MRI and the tags contrast-agents-gaps-2026-11, diagnostic.
Shares Gadolinium-based and other MRI contrast agents, GE HealthCare, Brain metastases (secondary brain tumours), MRI and the tags contrast-agents-gaps-2026-11, diagnostic.
Shares Gadolinium-based and other MRI contrast agents, Brain metastases (secondary brain tumours), MRI, Glioma & glioblastoma and the tags contrast-agents-gaps-2026-11, diagnostic.
Shares Gadolinium-based and other MRI contrast agents, GE HealthCare, MRI and the tags contrast-agents-gaps-2026-11, diagnostic.
Shares Gadolinium-based and other MRI contrast agents, Brain metastases (secondary brain tumours), MRI, Glioma & glioblastoma and the tags contrast-agents-gaps-2026-11, diagnostic.
Shares Gadolinium-based and other MRI contrast agents, Bayer, MRI and the tags contrast-agents-gaps-2026-11, diagnostic.
Shares Gadolinium-based and other MRI contrast agents, GE HealthCare, MRI and the tags contrast-agents-gaps-2026-11, diagnostic.
Shares Gadolinium-based and other MRI contrast agents, MRI, Glioma & glioblastoma and the tags contrast-agents-gaps-2026-11, diagnostic.
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