Filing of a marketing authorization application for Sinerem
At the end of November, Guerbet filed a marketing authorization application with the EMEA ....
At the end of November, Guerbet filed a marketing authorization application with the European Medicines Agency (EMEA) for Sinerem*, application that will be reviewed by the United Kingdom and Ireland. In Switzerland, Guerbet has to filed an application for Sinerem according to the normal procedure early December.
Subject to marketing authorizations' obtention, Guerbet plans to launch Sinerem in Europe as early as the second quarter of 2008.
As a reminder, Sinerem is an innovative Magnetic Resonance Imaging (MRI) contrast medium designed for characterization of lymph nodes in the evaluation of primary pelvic cancers spread. Sinerem allows imaging of lymph nodes by darkening normal ones while metastatic lymph nodes will appear white/bright, giving new information for further treatment decision.
*Sinerem is developed under license from Advanced Magnetics Inc.