Apixaban Accord

apixaban

Table of contents

Opinion

On 28 May 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Apixaban Accord, intended for the treatment and prevention of venous thromboembolic events (VTE) in adult patients and for the prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF). The applicant for this medicinal product is Accord Healthcare S.L.U.

Apixaban Accord will be available as 2.5 mg and 5 mg film-coated tablets. The active substance of Apixaban Accord is apixaban, an anticoagulant, (ATC code: B01AF02) which acts as a direct and highly selective inhibitor of factor Xa.

Apixaban Accord is a generic of Eliquis, which has been authorised in the EU since 18 May 2011. Studies have demonstrated the satisfactory quality of Apixaban Accord, and its bioequivalence to the reference product Eliquis. A question and answer document on generic medicines can be found here.

The full indication is:

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).

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

Key facts

Name
Apixaban Accord
Agency product number
EMEA/H/C/005358
International non-proprietary name (INN) or common name
  • apixaban
Active substance
  • Apixaban
Therapeutic area
Venous Thromboembolism
Stroke
Arthroplasty
Generic

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Date opinion adopted
28/05/2020
Company name
Accord Healthcare S.L.U.
Status
Positive
Application type
Initial authorisation

More information on Apixaban Accord

How useful was this page?

Add your rating
Average
1 rating