Ticagrelor tablet

Form: Tablet

Strength: 90 mg, 60 mg

Reference Brands: Brilinta(US & EU)

Category: Blood Disorder

Ticagrelor, marketed as Brilinta, is approved in both the US by the FDA and in the EU via EMA for acute coronary syndrome and other cardiovascular indications. Regulatory approval requires a comprehensive dossier including clinical efficacy, safety data, manufacturing details, and pharmacovigilance plans. In the US, FDA review involves detailed submission of clinical trial results, while in the EU, EMA approval follows strict regional guidelines. For guidance on dossier preparation, regulatory pathways, and successful market entry strategies, visit PharmaTradz. Ensuring compliance with regional regulations is essential for the safe and effective commercialization of ticagrelor worldwide.