CPhI Online

Pipeline - Apixaban Product Profile

14 Apr 2021

Apixaban Film Coated Tablets 2.5mg & 5mg
Reference Product: Eliquis® / Bristol-Myers Squibb/Pfizer

Description: Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults  for haemodynamically unstable PE patients.
Dossier Status: On-going 
Stability Studies: Zone II / Zone IVb
Shelf life (Originator): Three (3) years
Batch Size: To be defined
Pack Sizes: To be defined / Originator pack: BT x 14, 20, 28, 56, 60, 168 and 200 film-coated tablets