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New EU Approvals

Executive Summary

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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