Eplerenone tablets
Form: Tablet
Strength: 25 mg and 50 mg
Reference Brands: Inspra(US & EU)
Category: Heart Disorder
Eplerenone tablets, marketed as Inspra, are approved in the US by the FDA and in the EU via EMA for managing hypertension and heart failure. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical and quality information, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional compliance supports timely approval, safe use, and global availability of eplerenone tablets, helping improve cardiovascular health worldwide and supporting effective management of hypertension and heart failure.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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