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  1. www.drugs.com › sfx › micardis-side-effectsMicardis Side Effects: Common, Severe, Long Term - Drugs.com

    26 Νοε 2023 · Micardis side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances. Some side effects may not be reported. You may report them to the FDA. Medical Disclaimer

  2. s3-us-west-2.amazonaws.com › drugbank › cite_thisexanta (ximelagatran) tablets nda 21-686 fda advisory committee...

    approval for the use of EXANTA® (ximelagatran) Tablets as: œ An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention of venous thromboembolism (VTE) after standard treatment for an episode of acute

  3. www.drugs.com › history › exantaExanta (ximelagatran): What is it and is it FDA approved ... -...

    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 ...

  4. www.epistemonikos.org › documents › d5cbed3121495cc3f3b87d547686e3b092d4cdc8EXANTA® (ximelagatran) Tablets NDA 21-686 FDA Advisory Committee...

    New Drug Application (NDA) 21-686, submitted by AstraZeneca LP (AstraZeneca), requests approval for the use of EXANTA® (ximelagatran) Tablets as: An oral 24-mg twice daily (bid) fixed dose for the long-term secondary prevention of venous thromboembolism (VTE) after standard treatment for an episode of acute VTE An oral 36-mg bid fixed dose ...

  5. en.wikipedia.org › wiki › XimelagatranXimelagatran - Wikipedia

    Side effects. Ximelagatran was generally well tolerated in the trial populations, but a small proportion (5–6%) developed elevated liver enzyme levels, which prompted the FDA to reject an initial application for approval in 2004. The further development was discontinued in 2006 following reports of hepatotoxicity.

  6. www.ema.europa.eu › en › medicinesMicardis - European Medicines Agency (EMA)

    However, the following side effects are seen in between 1 and 10 patients in 1,000: upper-respiratory-tract infection (colds) including inflammation of the throat and sinuses, urinary-tract infection (infection of the structures that carry urine) including bladder infection, anaemia (low red-blood-cell counts), hyperkalaemia (high blood ...

  7. www.fda.gov › files › about fdaHigh Blood Pressure - Medicines to Help You rev. May 2011b - U.S....

    blood pressure medicines. The guide lists all of the FDA-approved products now available to treat this condition. You will also find some general information to help you use your medicines...