New EU Approvals
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to add six new products, including Vyepti, Lundbeck’s drug for the prophylaxis of migraine.
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The UK says a “proportionate” approach to tackling monkeypox is needed, and that Imvanex is now available for vaccination. France has issued a decree authorizing the use of Imvanex and the importation of its US equivalent, Jynneos, and Germany has ordered thousands of doses of the vaccine. SIGA’s antiviral tecovirimat can also be used for monkeypox in the EU.
Investigational products from Ultragenyx and MinervaX secured a place on the European Medicines Agency’s priority medicines scheme this month.
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.