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EMEA Clears Four Biologics In 1999 Before FDA, And Five Later Than FDA

Executive Summary

The European Medicines Evaluation Agency approved four biological products in 1999 that have not yet been licensed by FDA.

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Product.......... Humate-P (S, V) Ingredient....... Antihemophilic factor/von Willebrand factor complex (human) Sponsor.......... Centeon Pharma GmbH Indication....... New indication for treatment of spontaneous and trauma-induced bleeding episodes in severe von Willebrand disease and in mild and moderate von Willebrand disease where use of desmopressin is known or suspected to be inadequate Date Approved.... 4/1/1999 Application No... 96-1099 Footnote......... Standard review; Orphan drug

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