Atorvastatin Calcium tablets
Form: Tablet
Strength: 10 mg, 20 mg, 40 mg, 80 mg
Reference Brands: lipitor(US & EU)
Category: Heart Disorder
Atorvastatin tablets, marketed as Lipitor, are approved in the US by the FDA and in the EU via EMA for managing hyperlipidemia and preventing cardiovascular disease. Regulatory approval requires a detailed dossier including clinical efficacy, safety profiles, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews clinical trial and quality data for approval, while the EMA ensures compliance with regional safety and manufacturing regulations. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Proper compliance supports timely approval, safe use, and worldwide availability of atorvastatin tablets, helping patients reduce cardiovascular risk and improve heart health globally.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
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