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European CHMP Opinions And MAA Updates

Executive Summary

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.

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EU's CHMP OKs Major New Uses for Hemlibra, Praluent, Forxiga – And More

Several major products have been recommended for wider indications in the EU, including Roche’s hemophilia drug Hemlibra, Sanofi’s Praluent in atherosclerotic disease, and AstraZeneca’s Forxiga for type 1 diabetes.

Teva’s Ajovy & Pfizer’s Vizimpro Get EU Thumbs Up From CHMP

The European Medicines Agency’s drug evaluation committee has recommended for approval Teva’s Ajovy for migraine and Pfizer’s Vizimpro for NSCLC, as well as two more biosimilar versions of adalimumab (AbbVie’s Humira) and generics of atazanavir and feboxustat.

Potential Cardiovascular Blockbuster Inclisiran Among New Filings At EMA

The European Medicines Agency has agreed to review pan-EU marketing applications for a number of new medicines.

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