EC OKs Wyeth ReFacto MA variation
US drug major Wyeth' UK subsidiary has received a positive decision from the European Commission for a variation of the marketing authorization for ReFacto moroctocog alfa (recombinant coagulation Factor VIII), a treatment for hemophilia A. The manufacturing process for ReFacto has been modified, and the name has been changed to ReFacto AF moroctocog alfa. The decision by the EC follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) on December 18, 2008.
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