Apixaban tablet

Form: Tablet

Strength: 2.5 mg, 5 mg

Reference Brands: Eliquis(US & EU)

Category: Blood Disorder

Apixaban is approved by regulatory authorities in both the EU and US for various indications, including stroke prevention in atrial fibrillation and treatment of DVT/PE. In the US, it is approved by the FDA, requiring a comprehensive dossier demonstrating safety, efficacy, and manufacturing quality. In the EU, approval is granted through the EMA’s centralized procedure, adhering to strict biosimilar and medicinal product standards. Accurate dossier preparation, including pharmacovigilance plans, stability data, and clinical trial evidence, is essential for market authorization. For expert guidance on regulatory strategy, dossier development, and market entry, visit PharmaTradz. Ensuring compliance facilitates smooth approval processes and successful commercialization worldwide.