Product/Composition:- | Evolocumab Subcutaneous Injection |
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Strength:- | 140 mg/mL |
Form:- | Subcutaneous Injection |
Reference Brands:- | Repatha(US & EU) |
MOQ | As per the manufacturer batch size |
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Evolocumab is a monoclonal antibody that inhibits PCSK9, increasing LDL receptor availability to clear LDL cholesterol from the blood. It effectively lowers LDL cholesterol levels, reduces cardiovascular risk, and supports long-term lipid management. Benefits include significant LDL reductions, improved heart health, and prevention of atherosclerotic events.
Evolocumab, marketed as Repatha, is approved in the US by the FDA and in the EU via EMA for lowering LDL cholesterol in patients with familial hypercholesterolemia or cardiovascular disease. Regulatory approval requires a detailed dossier including clinical trial efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical and quality documents, while the EMA assesses regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional adherence supports timely approval, safe use, and global availability of evolocumab, helping improve cardiovascular health outcomes worldwide.