Evolocumab Subcutaneous Injection

Form: Subcutaneous Injection

Strength: 140 mg/mL

Reference Brands: Repatha(US & EU)

Category: Heart Disorder

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.