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Results of sensitivity analyses, and of secondary and tertiary endpoint analyses, confirmed that of the primary analysis and demonstrated robustness of these results.
1 Οκτ 2024 · Recalls, Market Withdrawals, & Safety Alerts. The list below provides information gathered from press releases and other public notices about certain recalls of FDA-regulated products. Not all ...
In this briefing document, AstraZeneca will provide the information necessary to make an assessment of the benefit-risk profile for ximelagatran as an oral anticoagulant and antithrombotic based on comparisons of ximelagatran to warfarin and to placebo.
A recall is an alternative to an FDA-initiated court action for removing or correcting violative products that have been distributed. 21 CFR 7 sets forth specific recall procedures for FDA to...
Ximelagatran (Exanta or Exarta, H 376/95) is an anticoagulant that has been investigated extensively as a replacement for warfarin [1] that would overcome the problematic dietary, drug interaction, and monitoring issues associated with warfarin therapy.
Exanta FDA Approval Status. FDA Approved: No. Brand name: Exanta. Generic name: ximelagatran. Company: AstraZeneca. Treatment for: Prevention of Thromboembolism in Atrial Fibrillation. Exanta (ximelagatran) is an investigational oral direct thrombin inhibitor (oral DTI) intended for use in the prevention of strokes in patients with atrial ...
22 Ιουλ 2021 · This article will provide an overview of recall procedures, their impact on the pharmaceutical industry, and the various steps taken to reduce pharmaceutical recalls.
