New EU Approvals
Executive Summary
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, including Novartis's Adakveo for preventing recurrent vaso-occlusive crises in patients with sickle cell disease. 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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New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include six new products, including Evrysdi, Roche/PTC Therapeutics' treatment for spinal muscular atrophy. 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).
European CHMP Opinions and MAA Updates
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.