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news.Novo Nordisk has formally notified the European Medicines Agency of its decision to withdraw the application for an extension of the marketing authorization for its bleeding prevention product, NovoSeven.
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NovoSeven (Human recombinant coagulation Factor VIIa (rFVIIa)) was first authorized in the European Union in February 1996 and is currently indicated for the treatment of bleeding episodes and prevention of bleeding during surgery or invasive procedures in specific patients with certain blood-clotting disorders.
In October 2005, Denmark-based Novo Nordisk submitted an application for the extension of the marketing authorization to include the treatment of acute intracerebral hemorrhage in adults for limiting hemorrhage growth and improving clinical outcomes.
Following review of the data submitted, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) requested that the company submit additional safety and efficacy data. In its official withdrawal letter, Novo Nordisk stated that, based on this request, it has decided to withdraw the current application and re-submit an application upon completion of an ongoing clinical study.