Product/Composition:- | Propafenone tablet |
---|---|
Strength:- | 150 mg, 300 mg |
Form:- | Tablet |
Reference Brands:- | Rhythmol(US & EU) |
MOQ | As per the manufacturer batch size |
Get Quote Send Enquiry on WhatsApp |
Propafenone tablets are antiarrhythmic agents that block sodium channels, slowing electrical conduction in the heart. They help restore normal rhythm by reducing abnormal impulses. Benefits include effective treatment of atrial and ventricular arrhythmias, decreased symptoms, improved heart stability, and enhanced quality of life for patients with irregular heartbeats.
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.