Valsartan tablet
Form: Tablets
Strength: 40 mg, 80 mg, 160 mg, 320 mg tablets
Reference Brands: Diovan(US & EU)
Category: Heart Disorder
Valsartan tablets, marketed as Diovan, are approved in the US by the FDA and in the EU via EMA for hypertension, heart failure, and reducing cardiovascular risk. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing quality, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and manufacturing data, while the EMA ensures compliance with regional safety and quality standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports timely approval, safe use, and worldwide availability, helping clinicians manage blood pressure and cardiovascular health effectively across regions.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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