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 (PDF/3.3 MB)
First published: 06/12/2022
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) |
|
Anatomical therapeutic chemical (ATC) code |
B01AF02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Bristol-Myers Squibb / Pfizer EEIG
|
Revision |
31
|
Date of issue of marketing authorisation valid throughout the European Union |
18/05/2011
|
Contact address |
Plaza 254 |
Product information
08/09/2022 Eliquis - EMEA/H/C/002148 - IAIN/0087/G
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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).