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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New treatments for congenital adrenal hyperplasia and relapsing forms of multiple sclerosis are among five drugs recommended for pan-EU approval this month. In addition, harmonized EU advice has been issued for Celltrion’s monoclonal antibody COVID-19 treatment.
Alexion is collecting more evidence to convince NICE that its anticoagulant reversal agent is also cost-effective for intracranial hemorrhage.
The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include six new products, including Evrysdi, Roche/PTC Therapeutics' treatment for spinal muscular atrophy. The list, which contains information dating back to January 2018, comprises brand name, generic name, company, therapeutic indication, date of marketing authorization announcement and product type (eg, medicine, vaccine, biologic).