New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include eight new products, including Roche's Rozlytrek (entrectinib) for the histology-independent indication of treatment of patients with NTRK fusion-positive solid tumors, and for treating patients with ROS1-positive advanced non-small cell lung cancer. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).
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This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.
New medicines under evaluation at the European Medicines Agency.