Sacubitril + Valsartan tablet
Form: Tablet
Strength: 24 mg/26 mg, 49 mg/51 mg, and 97 mg/103 mg
Reference Brands: Entresto: (US and EU)
Category: Heart Disorder
Sacubitril + Valsartan tablets, marketed as Entresto, are approved in the US by the FDA and in the EU via EMA for heart failure with reduced ejection fraction. Regulatory approval requires comprehensive dossiers including clinical efficacy, safety data, manufacturing standards, and post-market surveillance plans. In the US, the FDA reviews detailed clinical trial and quality data, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring compliance supports timely approval, safe use, and global availability of sacubitril/valsartan tablets, helping improve outcomes for heart failure patients worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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