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.
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New products from Paion, Arvelle, Incyte and many others have been recommended for approval by the European Medicines Agency. Meanwhile, the agency has explained why the EU marketing authorization application for Dexamethasone Taw, for treating COVID-19 patients, was withdrawn.
The European Medicines Agency has recommended in favor of approval for Amarin’s fish-oil derivative, Vazkepa.
Karyopharm says its treatment for patients with refractory multiple myeloma could become its first product to be approved in Europe.