New EU Approvals
Executive Summary
The Pink Sheet’s list of EU centralized approvals of new active substances has been updated with seven new products including Roche's Polivy for treating diffuse large B-cell lymphoma. The list, which contains information dating back to January 2018, includes brand name, generic name, company, therapeutic indication, date of marketing authorization and product type (eg, medicine, vaccine, biologic).
The Pink Sheet’s regularly updated list of products containing new active substances that have been approved for marketing in the EU under the centralized authorization procedure now includes seven new products.
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 (the CHMP) 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 21 January 2020. It includes information dating back to January 2018.
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