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European Performance Tracker

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EU Accelerated Assessment Tracker

Roche has secured accelerated assessment at the European Medicines Agency for its new immunosuppressant, satralizumab. The outcomes of five other fast-track requests that companies have made for their planned marketing authorization applications are still unknown.

Europe European Performance Tracker

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 three new products including GW Pharmaceuticals' Epidyolex (cannabidiol) for treating patients with epilepsy. 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).

Europe Approvals

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 Europe

EU Biosimilar Filings, Opinions And Approvals

A list of new EU biosimilar product filings, CHMP opinions and marketing authorizations issued by the European Commission. The updated list includes the filing of the first biosimilar version of insulin aspart and the approval of the EU’s sixth biosimilar pegfilgrastim product.

European Performance Tracker Approvals

EU Accelerated Assessment Tracker

Will Chugai's European marketing authorization application for satralizumab be fast-tracked when the company files for approval? The European Medicines Agency's drug evaluation committee, the CHMP, will decide this week.

Europe European Performance Tracker
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