CHMP recommends NovoEight for treatment of Haemophilia
Novo Nordisk announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) adopted a positive opinion on its recombinant factor VIII product turoctocog alfa, with the intended brand name NovoEight. The Committee recommended marketing authorisation for NovoEight for the treatment and prophylaxis of bleeding in patients with Haemophilia A.
NovoEight is based on advanced protein and purification technology, NovoEight has been designed for reliability, safety and portability for people with Haemophilia A. Following the Commission's approval, Novo Nordisk expects to launch NovoEight in Europe early 2014. The product has also been filed for marketing authorisation in the US, Japan, Australia and Switzerland.
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