Ezetimibe tablet
Form: Tablet
Strength: 10 mg
Reference Brands: Zetia(US), Ezetrol(EU)
Category: Heart Disorder
Ezetimibe tablets, marketed as Zetia in the US and Ezetrol in the EU, are approved for lowering LDL cholesterol by inhibiting intestinal absorption. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality information, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and global availability, enabling effective lipid management and cardiovascular risk reduction worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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