EU CHMP

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 EU, and updates on EU marketing authorization changes recommended by the CHMP.

Elinzanetant, Bayer’s investigational treatment for hot flashes in menopausal women, is among the latest drugs that have been filed for review by the European Medicines Agency for potential EU marketing approval.

Advanz Pharma, the company that markets Ocaliva for primary biliary cholangitis in the EU, will continue to supply the drug on a compassionate use or named patient basis.

The European Medicines Agency has recommended against EU marketing approval for two drugs targeting children.