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U.S. Food and Drug Administration - YouTube. The Food and Drug Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and...
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...
29 Οκτ 2024 · Dr. Elder: Yes. A class I recall is the most serious, where there is a reasonable probability that using or being exposed to the recalled drug will cause serious adverse health consequences for a ...
EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee Briefing Document 3 Development of ximelagatran The efficacy and safety of ximelagatran has been studied in a broad range of thrombogenic states in large, worldwide, comparator-controlled, and primarily outcome-based clinical studies.
1 Οκτ 2024 · Guidance for Industry and FDA Staff: Questions and Answers Regarding Mandatory Food Recalls; Initiation of Voluntary Recalls Under 21 CFR Part 7, Subpart C
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 fibrillation, for the prevention ...
