European CHMP Opinions And MAA Updates
This is a monthly 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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The latest list of marketing authorization applications under review by the European Medicines Agency includes filings for eight new products.
Viela and Roche both now have marketing applications that are being reviewed by the European Medicines Agency. If approved in the EU, their products will compete with Alexion’s blockbuster Soliris.
Most of the products currently supplied under Australia’s custom-made medical device exemption will no longer be eligible for supply in this way.