Swedish regulatory authorities have granted approval to Schering to sell its Resovist product, the first regulatory clearance for the MRI liver contrast agent. Based on the approval, Schering expects to receive European Union marketing clearance of Resovist within the next six months, as Sweden serves as a European reference member state for the EU's mutual recognition procedure.
Developed by Schering in cooperation with Meito Sangyo of Japan, Resovist is used for the detection and characterization of especially small focal liver lesions, which can be relevant in the early detection of hepatic carcinoma or metastases, according to Berlin-based Schering. The agent is injected as an intravenous bolus, allowing for immediate imaging of the liver and reductions in overall examination time, according to the company.
Resovist has been submitted for registration in several other countries worldwide, according to the firm. Schering is scheduled to launch Resovist in Sweden in mid-2001.
By AuntMinnie.com staff writersMarch 28, 2001
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