European CHMP issues positive opinion for a label update of Brintellix® (vortioxetine) to reflect its effect on certain aspects of cognitive function in patients with depression
For non US. Media onlyH. Lundbeck A/S (Lundbeck) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for a Type-II Variation related to the update of the European summary of the product characteristics (SmPC) for Brintellix. The update of the SmPC provides physicians with new Brintellix data related to its effect on certain aspects of cognitive function and patient functioning in general, as measured by cognitive performance assessment (neuropsychological test such as Digit Symbol Substitution