Apixaban Accord (apixaban)
- Region
- 🇪🇺 EU
- Active substance
- apixaban
- Company
- Accord Healthcare S.L.U.
- Status
- Authorised
- Therapeutic area
- Venous Thromboembolism; Stroke; Arthroplasty
- CHMP opinion
- Thu 28 May 2020
- EU approval
- Thu 23 Jul 2020
- Designations
- Generic
- Application
- EMEA/H/C/005358
- ATC
- B01AF02
- Official record
- www.ema.europa.eu
Indication
Adults 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 (see section 4.4 for haemodynamically unstable PE patients). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Adults Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. 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 (see section 4.4 for haemodynamically unstable PE patients). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Eliquis Authorised · Bristol-Myers Squibb / Pfizer EEIG
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.