Prasugrel tablet

Form: Tablet

Strength: 5 mg, 10 mg

Reference Brands: Effient(EU & US)

Category: Blood Disorder

Prasugrel, marketed as Effient, is approved by the FDA in the US and the EMA in the EU for reducing thrombotic events in acute coronary syndrome patients undergoing PCI. Regulatory approval requires a comprehensive dossier with clinical trial data, safety, efficacy, manufacturing, and pharmacovigilance details. In the US, FDA submission involves detailed review, while the EMA's centralized procedure ensures adherence to regional standards. For guidance on dossier preparation, regulatory pathways, and market access strategies, visit PharmaTradz. Ensuring compliance with regional regulations is vital for the successful approval, commercialization, and safe use of prasugrel across global markets.