Apixaban Accord

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apixaban

Authorised
This medicine is authorised for use in the European Union.

Overview

Apixaban Accord is a medicine used to prevent venous thromboembolism (blood clots in the veins) in adults following a hip or knee replacement operation. It is also used in adults to treat deep vein thrombosis (blood clot in a deep vein, usually in the leg) and pulmonary embolism (clot in a blood vessel supplying the lungs), and to prevent their reoccurrence.

Additionally, Apixaban Accord is used to prevent stroke (caused by blood clots in the brain) and blood clots in other organs in adults with atrial fibrillation (irregular rapid contractions of the upper chambers of the heart). It is used in patients who have one or more risk factors, such as having had a previous stroke, having high blood pressure, diabetes, heart failure or being 75 years old or over.

Apixaban Accord contains the active substance apixaban.

Apixaban Accord is a ‘generic medicine’.

This EPAR was last updated on 06/08/2020

Authorisation details

Product details
Name
Apixaban Accord
Agency product number
EMEA/H/C/005358
Active substance
Apixaban
International non-proprietary name (INN) or common name
apixaban
Therapeutic area (MeSH)
  • Venous Thromboembolism
  • Stroke
  • Arthroplasty
Anatomical therapeutic chemical (ATC) code
B01AF02
GenericGeneric

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.

Publication details
Marketing-authorisation holder
Accord Healthcare S.L.U.
Date of issue of marketing authorisation valid throughout the European Union
23/07/2020
Contact address

World Trade Center
Moll de Barcelona
s/n, Edifici Est 6ª planta
08039 Barcelona
Spain

Product information

23/07/2020 Apixaban Accord - EMEA/H/C/005358 -

Contents

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Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

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).

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).

Assessment history

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