Pravastatin

Form: Tablet

Strength: 10 mg, 20 mg, 40 mg, 80 mg

Reference Brands: Pravachol(US & EU)

Category: Heart Disorder

Pravastatin tablets, marketed as Pravachol, are approved in the US by the FDA and in the EU via EMA for managing hyperlipidemia and preventing cardiovascular disease. Regulatory approval requires a detailed dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews comprehensive clinical trial and manufacturing data, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring accurate regional compliance supports timely approval, safe use, and worldwide availability of pravastatin tablets, helping millions worldwide lower LDL cholesterol and mitigate cardiovascular risk effectively.