During the meeting of the Committee for Medicinal Products for Human Use ("CHMP"), 11 new medicines were recommended for approval. The CHMP's recommendations included marketing authorizations for: Opdivo, for the treatment of adults with advanced (unresectable or metastatic) melanoma; Hetlioz, for treatment of non-24-hour sleep–wake disorder in totally blind adults; Lixiana, for the prevention of stroke and systemic embolism in atrial fibrillation and the prevention and treatment of venous thromboembolism; and LuMark for the radio-labeling of carrier molecules. The agency also granted a positive opinion for seven generic medicines and adopted a negative opinion for Lympreva, which was intended for the treatment of patients with follicular non-Hodgkin lymphoma.
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