Human medicines European public assessment report (EPAR): Eliquis, apixaban, Date of authorisation: 18/05/2011, Revision: 40, Status: Authorised

Eliquis RSS Authorised This medicine is authorised for use in the European Union apixaban Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision 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. Expand section Collapse section How is Eliquis used? Eliquis can only be obtained with a prescription. It is available as tablets (2.5 mg, 5 mg). For patients who have had a hip or knee replacement, treatment with Eliquis should be started 12 to 24 hours after the operation. The recommended dose is one 2.5 mg tablet taken by mouth twice a day, usually for over one month (32 to 38 days) after a hip replacement or for 10 to 14 days after a knee replacement. For patients with atrial fibrillation at risk of stroke or blood clots, the recommended dose is 5 mg taken twice a day. For the treatment of deep vein thrombosis and pulmonary embolism, the recommended dose is 10 mg twice a day for the first week, followed by 5 mg twice a day for at least 3 months. To prevent deep vein thrombosis and pulmonary embolism from reoccurring, the recommended dose is 2.5 mg twice a day. For more information about using Eliquis, see the package leaflet or contact your doctor or pharmacist. How does Eliquis work? Patients undergoing hip or knee replacement surgery, who have had a recent trauma, or are confined to bed are at a high risk of blood clots forming in the veins, which can be dangerous and even fatal if they move to another part of the body such as the lungs. Similarly, patients with atrial fibrillation are at high risk of clots forming in the heart, which can reach the brain where they can cause a stroke. The active substance in Eliquis, apixaban, is a ‘factor Xa inhibitor’. This means that it blocks factor Xa, an enzyme that is involved in the production of thrombin. Thrombin is central to the process of blood clotting. By blocking factor Xa, it reduces the levels of thrombin in the blood, which reduces the risk of blood clots forming in the arteries and veins. What benefits of Eliquis have been shown in studies? Eliquis was effective at preventing blood clots in the veins following a hip or knee replacement in two main studies involving a total of 8,464 patients. In both studies, Eliquis was compared with enoxaparin (another medicine used to prevent blood clots). The medicine’s effectiveness was measured by looking at the number of patients who either had problems related to clotting in the veins or who died of any cause during the treatment period. In patients undergoing a hip replacement, 1.4% of the patients who completed treatment with Eliquis (27 out of 1,949) had a clotting event or died from any cause, compared with 3.9% (74 out of 1,917) of the patients taking enoxaparin. In patients undergoing a knee replacement, the corresponding numbers were 15% (147 out of 976) for Eliquis compared with 24% (243 out of 997) for enoxaparin. Eliquis was also shown to be effective in preventing strokes and arterial blood clots in patients with atrial fibrillation in two main studies: the first (in 18,201 patients) compared Eliquis with another medicine, warfarin, while the second (in 5,598 patients) compared Eliquis with aspirin. The main measures of effectiveness were based on the number of strokes or clotting events that occurred during treatment. In the study comparing Eliquis with warfarin, 1.3 % of the patients taking Eliquis had a stroke or clotting event every year compared with 1.6% of the patients taking warfarin. The yearly rates in the second study were 1.6% for patients taking Eliquis and 3.6% for patients taking aspirin. Eliquis was also effective at treating deep vein thrombosis and pulmonary embolism and preventing their reoccurrence in two main studies. In the treatment study conducted in 5,395 patients, Eliquis was compared with enoxaparin followed by warfarin; the main measure of effectiveness was based on the number of patients who either had blood clots in the veins of the legs or lungs or died because of this during the treatment period. 2.3% of patients treated with Eliquis had a clot or died, compared with 2.7% of patients treated with enoxaparin plus warfarin, showing that Eliquis was as effective as the comparator treatment. In the prevention study in 2,482 patients, Eliquis was compared with placebo (a dummy treatment) and its effectiveness was measured by looking at the number of patients who either had problems related to clotting in the veins or who died of any cause during treatment. 2.3% of patients taking Eliquis (2.5 mg twice a day) experienced a clot or died, compared with 9.3% of patients taking placebo. What are the risks associated with Eliquis? The most frequent side effects with Eliquis (seen in between 1 and 10 patients in 100) are anaemia (low red blood cell counts), haemorrhage (bleeding), haematoma (a collection of blood under the skin), contusion (bruising), nausea (feeling sick), low blood pressure (hypotension), epistaxis (nose bleeds), haematuria (blood in urine), low blood platelet counts (thrombocytopenia), blood tests showing alanine aminotransferase and gamma-glutamyltransferase increase and skin rash. Some of these side effects are not seen with all the uses of Eliquis. Eliquis must not be used in patients who are actively bleeding, or who have liver disease which leads to problems with blood clotting and an increased risk of bleeding. The medicine must also not be used in patients with conditions putting them at risk of major bleeding, such as an ulcer in the gut, or in patients being treated with other anticoagulant medicines except in specific circumstances (see summary of product characteristics). For the full list of side effects and restrictions with Eliquis, see the package leaflet. Why is Eliquis authorised in the EU? The European Medicines Agency decided that Eliquis’ benefits are greater than its risks and it can be authorised for use in the EU. What measures are being taken to ensure the safe and effective use of Eliquis? The company that markets Eliquis will provide educational material for healthcare professionals expected to prescribe Eliquis that addresses the risk of bleeding during treatment. Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Eliquis have also been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Eliquis are continuously monitored. Side effects reported with Eliquis are carefully evaluated and any necessary action taken to protect patients. Other information about Eliquis Eliquis received a marketing authorisation valid throughout the EU on 18 May 2011. Eliquis : EPAR - Summary for the public Reference Number: EMA/416082/2018 English (EN) (81.54 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View Other languages (22) български (BG) (126.38 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View español (ES) (102.36 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View čeština (CS) (122.29 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View dansk (DA) (101.96 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View Deutsch (DE) (103.09 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View eesti keel (ET) (100.33 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View ελληνικά (EL) (132.96 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View français (FR) (104.35 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View hrvatski (HR) (117.72 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View italiano (IT) (102.45 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View latviešu valoda (LV) (130.48 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View lietuvių kalba (LT) (121.47 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View magyar (HU) (117.73 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View Malti (MT) (122.58 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View Nederlands (NL) (105.51 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View polski (PL) (121.59 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View português (PT) (102.46 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View română (RO) (120.07 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View slovenčina (SK) (121.46 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View slovenščina (SL) (115.39 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View Suomi (FI) (101.92 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View svenska (SV) (101.68 KB - PDF) First published: 20/06/2011 Last updated: 01/08/2018 View Eliquis : EPAR - Risk Management Plan English (EN) (19.64 MB - PDF) First published: 06/12/2022 Last updated: 01/04/2026 View Product information Eliquis : EPAR - Product Information English (EN) (1.76 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View Other languages (24) български (BG) (1.77 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View español (ES) (2.21 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View čeština (CS) (1.72 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View dansk (DA) (2.22 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View Deutsch (DE) (2.34 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View eesti keel (ET) (1.52 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View ελληνικά (EL) (1.79 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View français (FR) (2.41 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View hrvatski (HR) (1.71 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View íslenska (IS) (1.52 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View italiano (IT) (2.24 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View latviešu valoda (LV) (1.74 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View lietuvių kalba (LT) (1.76 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View magyar (HU) (1.79 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View Malti (MT) (1.88 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View Nederlands (NL) (2.22 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View norsk (NO) (2.21 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View polski (PL) (1.81 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View português (PT) (2.19 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View română (RO) (1.74 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View slovenčina (SK) (1.88 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View slovenščina (SL) (1.71 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View Suomi (FI) (2.3 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View svenska (SV) (2.21 MB - PDF) First published: 20/06/2011 Last updated: 10/04/2026 View Latest procedure affecting product information: VR/0000319463 01/04/2026 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). Eliquis : EPAR - All Authorised presentations English (EN) (70.2 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View Other languages (24) български (BG) (64.29 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View español (ES) (73.21 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View čeština (CS) (59.31 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View dansk (DA) (70.55 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View Deutsch (DE) (71.15 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View eesti keel (ET) (51.77 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View ελληνικά (EL) (60.05 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View français (FR) (70.39 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View hrvatski (HR) (54.95 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View íslenska (IS) (54.08 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View italiano (IT) (68.21 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View latviešu valoda (LV) (56.13 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View lietuvių kalba (LT) (58.04 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View magyar (HU) (58.99 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View Malti (MT) (56.97 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View Nederlands (NL) (55.73 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View norsk (NO) (71.26 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View polski (PL) (56.95 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View português (PT) (71.08 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View română (RO) (56.23 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View slovenčina (SK) (58.26 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View slovenščina (SL) (54.84 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View Suomi (FI) (69.86 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View svenska (SV) (70.39 KB - PDF) First published: 20/06/2011 Last updated: 12/03/2026 View Product details Name of medicine Eliquis Active substance apixaban International non-proprietary name (INN) or common name apixaban Therapeutic area (MeSH) Arthroplasty Venous Thromboembolism Anatomical therapeutic chemical (ATC) code B01AF02 Pharmacotherapeutic group Antithrombotic agents Therapeutic indication Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Adults 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). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Adults 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). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Authorisation details EMA product number EMEA/H/C/002148 Marketing authorisation holder Bristol-Myers Squibb / Pfizer EEIG Plaza 254 Blanchardstown Corporate Park 2 Dublin 15 D15 T867 Ireland Opinion adopted 17/03/2011 Marketing authorisation issued 18/05/2011 Revision 40 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Eliquis : EPAR - Procedural steps taken and scientific information after authorisation English (EN) (160.03 KB - PDF) First published: 29/09/2025 Last updated: 01/04/2026 View Eliquis : EPAR - Procedural steps taken and scientific information after authorisation (archive) English (EN) (330.11 KB - PDF) First published: 20/12/2012 Last updated: 29/09/2025 View Eliquis-H-C-PSUSA-00000226-202405 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/130522/2025 English (EN) (143.29 KB - PDF) First published: 14/04/2025 View Eliquis-H-C-2148-X-0089-G : EPAR - Assessment Report - Variation Reference Number: EMA/281735/2024 English (EN) (3.99 MB - PDF) First published: 19/08/2024 View CHMP post-authorisation summary of positive opinion for Eliquis (X-89-G) Reference Number: EMA/CHMP/247780/2024 English (EN) (189.73 KB - PDF) First published: 31/05/2024 View Eliquis-H-C-2148-II-0088 : EPAR - Assessment Report - Variation Adopted Reference Number: EMA/CHMP/226986/2023 English (EN) (3.68 MB - PDF) First published: 23/06/2023 View Eliquis : EPAR - Paediatric investigation plan compliance statement Reference Number: EMA/CHMP/231524/2023 English (EN) (118.51 KB - PDF) First published: 23/06/2023 View Eliquis-H-C-2148-P46-039 : EPAR - Assessment report Adopted Reference Number: EMA/899943/2022 English (EN) (2.44 MB - PDF) First published: 21/12/2022 View Eliquis-H-C-PSUSA-00000226-202105 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/201095/2022 English (EN) (119.93 KB - PDF) First published: 04/04/2022 View Eliquis-H-C-PSUSA-00000226-202005 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation Reference Number: EMA/259527/2021 English (EN) (127.32 KB - PDF) First published: 11/05/2021 View Eliquis-H-C-PSUSA-00000226-201905 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation Reference Number: EMA/56836/2020 English (EN) (121.17 KB - PDF) First published: 17/03/2020 View Eliquis-H-C-PSUSA-226-201605: Scientific conclusions and grounds for the variation to the terms of the marketing authorisation(s) Reference Number: EMA/859610/2016 English (EN) (79.03 KB - PDF) First published: 22/02/2017 Last updated: 22/02/2017 View Eliquis-H-C-PSUSA-00000226-201505 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation Reference Number: EMA/709998/2015 English (EN) (68.3 KB - PDF) First published: 30/10/2015 Last updated: 30/10/2015 View Eliquis-H-C-2148-II-0014-G : EPAR - Assessment Report - Variation Adopted Reference Number: EMA/478338/2014 English (EN) (2.53 MB - PDF) First published: 29/09/2014 Last updated: 29/09/2014 View CHMP post-authorisation summary of positive opinion for Eliquis Adopted Reference Number: EMA/CHMP/360384/2014 English (EN) (71.9 KB - PDF) First published: 27/06/2014 Last updated: 27/06/2014 View Eliquis-H-C-2148-PSUV-0012 : EPAR - Scientific conclusions and grounds recommending the variation to the terms of the marketing authorisation Adopted Reference Number: EMA/CHMP/374542/2013 English (EN) (72.54 KB - PDF) First published: 19/09/2013 Last updated: 19/09/2013 View Eliquis-H-C-2148-X-0004-G : EPAR - Assessment Report - Extension Adopted Reference Number: EMA/641505/2012 English (EN) (2.59 MB - PDF) First published: 20/12/2012 Last updated: 20/12/2012 View CHMP post-authorisation summary of positive opinion for Eliquis Adopted Reference Number: EMA/CHMP/608476/2012 English (EN) (77.5 KB - PDF) First published: 21/09/2012 Last updated: 21/09/2012 View Initial marketing authorisation documents Eliquis : EPAR - Public assessment report Adopted English (EN) (1.35 MB - PDF) First published: 20/06/2011 Last updated: 20/06/2011 View CHMP summary of positive opinion for Eliquis Adopted Reference Number: EMA/CHMP/87152/2011 English (EN) (123.25 KB - PDF) First published: 18/03/2011 Last updated: 18/03/2011 View News on Eliquis Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 May 2024 31/05/2024 No change is needed in use of direct oral anticoagulants following EMA-funded study 27/03/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 June 2014 27/06/2014 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 September 2012 21/09/2012 Product information – with tracked changes The approved product information for this medicine is available below showing the changes since the previous procedure affecting the product information. The same document without tracked changes is above under 'Product information'. Eliquis : EPAR – Product information - tracked changes English (EN) (1001.13 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View Other languages (24) български (BG) (1.12 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View español (ES) (978.15 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View čeština (CS) (1.02 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View dansk (DA) (922.92 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View Deutsch (DE) (984.75 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View eesti keel (ET) (946.1 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View ελληνικά (EL) (1.11 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View français (FR) (1000.47 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View hrvatski (HR) (1.08 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View íslenska (IS) (1.04 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View italiano (IT) (976.5 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View latviešu valoda (LV) (1.03 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View lietuvių kalba (LT) (988.21 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View magyar (HU) (1.08 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View Malti (MT) (1.04 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View Nederlands (NL) (932.4 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View norsk (NO) (969.22 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View polski (PL) (1.07 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View português (PT) (968.37 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View română (RO) (1.03 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View slovenčina (SK) (1.03 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View slovenščina (SL) (1.02 MB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View Suomi (FI) (983.39 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View svenska (SV) (959.98 KB - DOCX) First published: 14/04/2025 Last updated: 10/04/2026 View More information on Eliquis No change is needed in use of direct oral anticoagulants following EMA-funded study Reference Number: EMA/94424/2020 English (EN) (160.71 KB - PDF) First published: 27/03/2020 View Related content Direct oral anticoagulants (DOACs) - Article 5(3) opinion More information on Eliquis EMEA-000183-PIP01-08-M08 - paediatric investigation plan EMEA-000183-PIP02-12-M05 - paediatric investigation plan Evaluating the Effectiveness of Eliquis® Additional Risk Minimization Measures in Kingdom of Saudi Arabia. - post-authorisation study Treatment Patterns of newly initiated oral anticoagulants on Japanese non-vascular atrial fibrillation patients using a Japanese claims database - post-authorisation study Safety and Effectiveness of Rivaroxaban and Apixaban compared to warfarin in non-valvular atrial fibrillation patients in the routine clinical practice in the UK (SiERRA UK) - post-authorisation study Venous Thromboembolism Treatment (VOLT) - post-authorisation study Beyond Pooled – Part of the BEYOND study program (Benefit of NOACs study of non-valvular AF patients in nordic countries) (BEYOND Pooled (Denmark, Norway, Sweden)) - post-authorisation study Risk of major bleeding and associated health care resource utilization in non-valvular atrial fibrillation patients who initiated NOACs vs VKAs in the Hungarian population. A stratification on the propensity score method study. - post-authorisation study Real World Evaluation of Venous Thromboembolism (VTE): Analysis of Electronic Health Record Data - post-authorisation study Real-world Comparisons of Stroke, Major Bleeding, Myocardial Infarction, Acute Limb Ischemia and Death among Non-Valvular Atrial Fibrillation Patients Diagnosed With Coronary Artery Disease/Peripheral Arterial Disease who Initiated Oral Anticoagulation Therapies (CAD PAD) - post-authorisation study Evaluation of the effectiveness of Eliquis® (apixaban) risk minimization tools in European - post-authorisation study Comparative risk of major bleeding with new oral anticoagulants (NOACs) and Phenprocoumon in patients with atrial fibrillation: a retrospective claims database study in Germany (CARBOS) - post-authorisation study POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN THE NETHERLANDS - post-authorisation study POST-APPROVAL SAFETY STUDY (PASS) OF THE UTILIZATION PATTERN OF APIXABAN IN SWEDEN - post-authorisation study Predictors of Treatment and the Comparative Clinical and Economic Outcomes among Non-Valvular Atrial Fibrillation Patients Treated versus Untreated with Oral Anticoagulant Therapy (NVAF Diagnosed Untreated) - post-authorisation study Hospital Readmissions Among Nonvalvular Atrial Fibrillation Patients Treated with Oral Anticoagulants in the U.S. - post-authorisation study Clinical and Economic Outcomes and Treatment Patterns for Non-Valvular Atrial Fibrillation Patients Who Newly Initiated Oral Anticoagulants in the US Medicare Population - post-authorisation study Comparative Clinical and Economic Outcomes among Venous Thromboembolism Patients who Initiated Apixaban or Warfarin in the United States Medicare Population (VTE CER in Medicare) - post-authorisation study Outcomes among venous thromboembolism patients who were admitted into the emergency department and treated with apixaban or warfarin in the U.S. (VTE CER in Premier ED) - post-authorisation study Oral Anticoagulant Use in Patients with Non Valvular Atrial Fibrillation: Analysis of Electronic Medical Record Data - post-authorisation study Voluntary PASS non interventional study: Retrospective Observational Study of VKA and Novel Oral Anticoagulants in Patients with Non-valvular Atrial Fibrillation: - post-authorisation study Topics Medicines This page was last updated on 01/04/2026 Share this page