ANFARM HELLAS S.A. sell "Apixaban F.C. Tabs 2.5mg/tab & 5mg/tab (under development)"

Apixaban Film-Coated Tablets, 2.5 mg and 5 mg, referencing Eliquis® (Bristol-Myers Squibb/Pfizer). Indicated for stroke and systemic embolism prevention in adults with non-valvular atrial fibrillation who have one or more risk factors (prior stroke or TIA, age 75+, hypertension, diabetes, symptomatic heart failure NYHA Class II+), as well as for treating deep vein thrombosis and pulmonary embolism and preventing their recurrence, including in hemodynamically unstable PE patients. Dossier status: ongoing. Stability studies: Zone II/Zone IVb. Originator shelf life: three years. Batch size: to be defined. Pack sizes: to be defined; originator packs of 14, 20, 28, 56, 60, 168, and 200 film-coated tablets.