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European Performance Tracker

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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.

Drug Review Approvals

New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Drug Review Europe

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances now includes three new products including Janssen's Erleada, a next generation oral androgen receptor inhibitor for treating adults with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease. 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 (e.g., medicine, vaccine, biologic).

Europe Approvals

EU Accelerated Assessment Tracker: Nine Definites So Far From 24 Requests In 2018

In 2018, the European Medicines Agency considered 24 requests from drug companies for fast-track review of their planned marketing authorization applications. The agency has granted at least nine requests, eleven have been rejected and the results of four have yet to be disclosed.

Europe Review Pathway

EU Biosimilar Filings, Opinions And Approvals

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

European Performance Tracker Approvals

New EU Approvals

Six new products, including Eli Lilly's breast cancer drug Verzenios, have been added to the Pink Sheet’s 2018 list of EU centralized approvals of new active substances. The list includes brand name, generic name, company, therapeutic category/indication, date of marketing authorization and product type (e.g., medicine, vaccine, biologic).
Approvals Europe
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