New EU Approvals
Executive Summary
A listing of EU centralized approvals of new active substances, including brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
This is a regularly updated listing of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure in 2018.
The great majority of new, innovative medicines and vaccines that are marketed in the EU go through the centralized procedure. The European Medicines Agency’s Committee for Medicinal Products for Human Use carries out a scientific assessment of the initial marketing authorization application (MAA) and gives a recommendation on whether the medicine should be marketed or not. CHMP recommendations are forwarded to the European Commission for a legally binding decision. Once granted, centralized marketing authorizations are valid in all EU member states as well as in the European Economic Area countries of Iceland, Liechtenstein and Norway.
The list is updated regularly with new approvals and is current as of June 28. Click on any column header to sort by that topic. The search box can be used to filter results.