Product/Composition:- | Trimetazidine tablet |
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Strength:- | 20 mg |
Form:- | Tablet |
Reference Brands:- | Vazocardin(EU) |
MOQ | As per the manufacturer batch size |
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Trimetazidine improves cardiac metabolism by shifting energy production from fatty acids to glucose, increasing efficiency during ischemic stress. It reduces angina symptoms, enhances exercise tolerance, and protects heart tissue. Benefits include decreased angina frequency, better blood flow, reduced myocardial injury, and improved quality of life in ischemic heart disease patients.
Trimetazidine tablets, marketed as Vazocardin, are approved in the EU for angina and ischemic heart disease but are not approved in the US. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the EU, the EMA reviews detailed clinical trial data and ensures compliance with regional safety standards. In the US, the FDA has not authorized trimetazidine for sale, citing safety concerns. For guidance on dossier preparation, regulatory pathways, and market entry strategies, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and worldwide availability, helping to optimize treatment for ischemic heart conditions.