Eliquis

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apixaban

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

Overview

Eliquis 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, Eliquis 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.

Eliquis contains the active substance apixaban.

This EPAR was last updated on 23/06/2023

Authorisation details

Product details
Name
Eliquis
Agency product number
EMEA/H/C/002148
Active substance
Apixaban
International non-proprietary name (INN) or common name
apixaban
Therapeutic area (MeSH)
  • Arthroplasty
  • Venous Thromboembolism
Anatomical therapeutic chemical (ATC) code
B01AF02
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb / Pfizer EEIG
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
18/05/2011
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

25/05/2023 Eliquis - EMEA/H/C/002148 - II/0088

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

For Eliquis 2.5 mg film-coated tablets:

  • 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).

For Eliquis 5 mg film-coated tablets:

  • 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

Changes since initial authorisation of medicine

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