EU 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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Amryt’s epidermolysis bullosa gel and Roche’s CD20xCD3 bispecific antibody for follicular lymphoma are among four drugs that have received the thumbs up from the European Medicines Agency.
The marketing application was withdrawn before the European Medicines Agency had finished re-examining its earlier recommendation to reject the drug.
The European Medicines Agency’s human medicines committee has recommended five new drugs for use in the EU at its latest monthly meeting.