Eliquis
apixaban
Table of contents
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.
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List item
Eliquis : EPAR - Summary for the public (PDF/81.54 KB)
First published: 20/06/2011
Last updated: 01/08/2018
EMA/416082/2018 -
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List item
Eliquis : EPAR - Risk-management-plan summary (PDF/276.62 KB)
First published: 15/11/2019
Authorisation details
Product details | |
---|---|
Name |
Eliquis
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Agency product number |
EMEA/H/C/002148
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Active substance |
Apixaban
|
International non-proprietary name (INN) or common name |
apixaban
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
B01AF02
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Publication details | |
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Marketing-authorisation holder |
Bristol-Myers Squibb / Pfizer EEIG
|
Revision |
23
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Date of issue of marketing authorisation valid throughout the European Union |
18/05/2011
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Contact address |
Product information
07/10/2020 Eliquis - EMEA/H/C/002148 - N/0078
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).