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European Performance Tracker

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New Filings At The EMA

New medicines under evaluation at the European Medicines Agency.

Europe Drug Review

New EU Approvals

The Pink Sheet’s list of EU centralized approvals of new active substances now includes two new products, one of which is the injectable migraine prevention drug, Ajovy (fremanezumab). 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).

Approvals Europe

EU Accelerated Assessment Tracker

Accelerated assessment requests at the European Medicines Agency. 
Review Pathway Europe

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.

Europe Approvals

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.
Europe European Performance Tracker

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
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