Alirocumab Subcutaneous Injection
Form: Subcutaneous Injection
Strength: 75 mg/mL and 150 mg/mL
Reference Brands: Praluent(US & EU)
Category: Heart Disorder
Alirocumab, marketed as Praluent, 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 risk. Regulatory approval requires a comprehensive dossier including clinical trial data, safety profiles, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical and quality data to ensure safety and efficacy, while the EMA evaluates regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regulatory adherence supports timely approval, safe use, and global availability of alirocumab subcutaneous injections, contributing to improved cardiovascular health worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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