Flecainide Tablet

Form: Tablet

Strength: 50 mg, 100 mg tablets

Reference Brands: Tambocor(EU & US)

Category: Heart Disorder

Flecainide tablets, marketed as Tambocor, are approved in the US by the FDA and in the EU via EMA for treating ventricular and supraventricular arrhythmias. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed 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 regulatory compliance supports timely approval, safe use, and worldwide availability of flecainide tablets, helping to manage cardiac rhythm disorders effectively across regions.