Ivabradine tablet
Form: Tablet
Strength: 5 mg, 7.5 mg, and 9 mg
Reference Brands: Corlanor(US), Procoralan(EU)
Category: Heart Disorder
Ivabradine tablets, marketed as Corlanor (US) and Procoralan (EU), are approved for chronic stable angina and heart failure management. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing standards, and pharmacovigilance plans. In the US, the FDA reviews detailed clinical trial and quality information, while the EMA ensures compliance with safety and manufacturing standards across European regions. For guidance on dossier preparation, regulatory pathways, and market access, visit PharmaTradz. Ensuring regional regulatory adherence supports timely approval, safe use, and worldwide availability of ivabradine tablets, helping improve heart rate management and reduce cardiovascular events globally.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Related Products
Aliskiren tablets
Strength: 150 mg, 300 mg
Form: Tablets
Reference Brands: Tekturna(US & EU)
View Details Get Enquiry
Atenolol tablets
Strength: 25 mg, 50 mg, 100 mg
Form: Tablets
Reference Brands: Tenormin(US)
View Details Get Enquiry
Metoprolol Tartrate tablet
Strength: IR: 25 mg, 50 mg, 100 mg; ER: 25 mg, 50 mg, 100 mg, 200 mg
Form: Tablets(IR & ER)
Reference Brands: US: Lopressor(IR); Toprol-XL(ER)
View Details Get Enquiry
Nifedipine tablets(IR/ER)
Strength: 10 mg, 20 mg, 30 mg, 60 mg, 90 mg (IR and ER forms)
Form: Tablet(IR & ER)
Reference Brands: Procardia(US);
View Details Get Enquiry