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EMA reaffirms positive benefit-risk balance of rivaroxaban for stroke prevention in AF patients
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The European Medicines Agency (EMA) has reaffirmed the positive benefit-risk balance of rivaroxaban (Xarelto) for stroke prevention in patients with atrial fibrillation. This outcome concludes a CHMP (Committee for Medicinal Products for Human Use) procedure that was initiated to assess whether a potential malfunctioning of the INR device used in the ROCKET AF trial had any impact on the study results. Bayer and its development partner Janssen have undertaken thorough analyses, which were shared with Health Authorities, in particular EMA and the FDA. Separately, the re-analysis conducted by the ROCKET AF Executive Committee, who ran the ROCKET AF trial, was
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