Eliquis

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apixaban

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

Overview

An overview of Eliquis and why it is authorised in the EU

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 03/09/2018

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
16
Date of issue of marketing authorisation valid throughout the European Union
18/05/2011
Contact address
Uxbridge Business Park
Sanderson Road
Uxbridge UB8 1DH
United Kingdom

Product information

03/08/2018 Eliquis - EMEA/H/C/002148 - IAIN/0056

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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