Propafenone tablet

Form: Tablet

Strength: 150 mg, 300 mg

Reference Brands: Rhythmol(US & EU)

Category: Heart Disorder

Propafenone tablets, marketed as Rhythmol, are approved in the US by the FDA and in the EU via EMA for treating atrial and ventricular arrhythmias. 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 information, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance supports timely approval, safe use, and global availability of propafenone tablets, helping healthcare providers manage arrhythmias effectively worldwide.