Triple Combination Therapy First For Asthma Among Eight Wins At EMA
Novartis is among a number of companies that this week moved closer to marketing new products across the EU. D&A Pharma has again failed to convince the European Medicines Agency that its alcohol dependence treatment should be approved.
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The May meeting of the European Medicines Agency’s drug evaluation committee, the CHMP, is under way. Decisions are due on whether eight marketing approval applications should be approved for marketing in the EU.
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.
A number of companies with marketing applications at the later stages of the EU review process are seeking extra time to address remaining concerns the European Medicines Agency’s drug evaluation committee, the CHMP, has about their filings.