European CHMP Opinions and MAA Updates
This is an 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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The European Medicine Agency has recommended extending the therapeutic indication of a raft of drugs that are already authorized in the EU.
While Accord HealthCare has convinced the European Medicines Agency that its rivaroxaban generic should be approved in the EU, Bayer has warned that patent protection for Xarelto continues until at least late 2023. The EMA this week also recommend approval for a number of other new drugs.
Antimicrobial resistance, the lack of new antibiotics, and preserving the effectiveness of existing ones are high on the agenda for the soon-to-be new head of the European Medicines Agency, Emer Cooke.