Trimetazidine tablet
Form: Tablet
Strength: 20 mg
Reference Brands: Vazocardin(EU)
Category: Heart Disorder
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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