European Medicines Agency Approves SmPC Change to Baxter International, Inc.’s ADVATE to Include Information on PK-Guided Dosing Study

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LONDON--(BUSINESS WIRE)--Baxter International Inc. (NYSE:BAX) today announced that the European Medicines Agency has authorized an update to the Summary of Product Characteristics (SmPC) for Baxter’s ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method, (in the EU, ADVATE, octocog alfa)] to include findings of the Phase IV prophylaxis study.

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