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September 17, 2018
Guerbet's Lipiodol Ultra Fluid Approved for New Indication in cTACE
September 18, 2018—Guerbet LLC announced that it has been granted approval for a new indication for the company's Lipiodol Ultra Fluid in Belgium, Ireland, Portugal, Hong Kong, and the Philippines, for selective hepatic intra-arterial injection for visualization, localization, and vectorization during conventional transarterial chemoembolization (cTACE) of tumors in adults with known, intermediate-stage hepatocellular carcinoma (HCC).
In the cTACE procedure, Lipiodol Ultra Fluid mixed with an anticancer drug is injected transarterially in the liver as a locoregional targeted chemotherapy for unresectable HCC. Lipiodol Ultra Fluid acts as a contrast agent, a drug-eluting vehicle, and a dual arterioportal transient embolic.
According to the company, cTACE and HCC imaging indications are now approved in Austria, Belgium, Czech Republic, France, Germany, Hungary, Iran, Ireland, the Netherlands, Portugal, Turkey, Cambodia, Hong Kong, Japan, Mongolia, New Zealand, Philippines, South Korea, Taiwan, Thailand, Vietnam, Canada, the United States, Argentina, Brazil, Mexico, and Peru. Other registrations are ongoing in Asia and in Europe. The approved indications for Lipiodol Ultra Fluid may vary according to countries; users should refer to the local summary of product characteristics for further information.
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