Product/Composition:- | Nebivolol tablets |
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Strength:- | 2.5 mg, 5 mg, and 10 mg |
Form:- | Tablets |
Reference Brands:- | Bystolic(US & EU) |
MOQ | As per the manufacturer batch size |
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Nebivolol is a selective beta-1 blocker that reduces heart rate and blood pressure. It enhances nitric oxide release, causing vasodilation and improving blood flow. Benefits include effective hypertension and heart failure management, decreased cardiovascular risk, improved cardiac function, and long-term health benefits with fewer side effects.
Nebivolol tablets, marketed as Bystolic, are approved in the US by the FDA and in the EU via EMA for hypertension and heart failure. Regulatory approval requires detailed dossiers including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews comprehensive clinical and quality data for timely approval, while the EMA ensures regional safety and manufacturing compliance. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper regional adherence supports rapid approval, safe use, and global availability of nebivolol tablets, helping patients worldwide manage cardiovascular health effectively and sustainably.