Rosuvastatin Calcium tablets
Form: Tablets
Strength: 5 mg, 10 mg, 20 mg, 40 mg
Reference Brands: Crestor(US & EU)
Category: Heart Disorder
Rosuvastatin tablets, marketed as Crestor, are approved in the US by the FDA and in the EU via EMA for managing hyperlipidemia and reducing cardiovascular risk. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. The FDA reviews detailed clinical trial and quality data for timely approval, while the EMA ensures compliance with regional safety and manufacturing standards. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper adherence to regional regulations supports prompt approval, safe use, and global availability of rosuvastatin tablets, helping reduce the risk of heart disease and support cardiovascular health worldwide.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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