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Novo Nordisk A/S receives positive opinion on Xultophy (IDegLira) from European regulatory authorities

Friday, 25 Jul 2014 07:28am EDT 

Novo Nordisk A/S:Announced that Committee for Medicinal Products for Human Use (CHMP) under European Medicines Agency (EMA) adopted positive opinion, recommending marketing authorisation for Xultophy for treatment of type 2 diabetes mellitus in adults.Xultophy is intended brand name for IDegLira, first once-daily single injection combination of Tresiba(insulin degludec) and Victoza(liraglutide), developed for treatment of type 2 diabetes.CHMP positive opinion recommends that Xultophy will be indicated for treatment of adults with type 2 diabetes mellitus to improve glycaemic control in combination with oral glucose-lowering medicinal products when these alone or combined with basal insulin do not provide adequate glycaemic control. 

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