Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Eliquis   
Auth. number : EU/1/11/691
Active substance : apixaban
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AF - Direct factor Xa inhibitors
Chemical substance: B01AF02 - apixaban
(See WHO ATC Index)
Indication: 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).
Marketing Authorisation Holder: Bristol-Myers Squibb/Pfizer EEIG
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
20/05/2011 Centralised - Authorisation EMEA/H/C/2148 (2011)3595 of 18/05/2011
20/04/2012 Centralised - Notification EMEA/H/C/2148/N/6
Updated with Decision(2012)8602 of 19/11/2012
23/11/2012 Centralised - Variation EMEA/H/C/2148/X/4/G (2012)8602 of 19/11/2012
12/02/2013 Centralised - Variation
Updated with Decision(2013)5609 of 26/08/2013
01/07/2013 Centralised - Notification EMEA/H/C/2148/N/13
Updated with Decision(2013)8164 of 15/11/2013
29/08/2013 PSUSA - Modification EMEA/H/C/2148/PSUV/12 (2013)5609 of 26/08/2013
18/11/2013 Centralised - Variation EMEA/H/C/2148/II/11 (2013)8164 of 15/11/2013
16/04/2014 Centralised - Variation EMEA/H/C/2148/IB/19
Updated with Decision(2014)5500 of 28/07/2014
25/04/2014 Centralised - Variation EMEA/H/C/2148/II/16
Updated with Decision(2014)5500 of 28/07/2014
25/04/2014 Centralised - Variation EMEA/H/C/2148/II/17
Updated with Decision(2014)5500 of 28/07/2014
12/06/2014 Centralised - Notification EMEA/H/C/2148/N/20
Updated with Decision(2014)5500 of 28/07/2014
30/07/2014 Centralised - 2-Monthly update EMEA/H/C/2148/II/14/G (2014)5500 of 28/07/2014
26/02/2015 Centralised - Notification EMEA/H/C/2148/N/26
Updated with Decision(2015)5974 of 20/08/2015
21/07/2015 Centralised - Notification EMEA/H/C/2148/N/32
Updated with Decision(2016)231 of 14/01/2016
24/08/2015 PSUSA - Modification EMEA/H/C/2148/PSUSA/226/201411 (2015)5974 of 20/08/2015
17/09/2015 Centralised - Variation EMEA/H/C/2148/II/29
Updated with Decision(2016)231 of 14/01/2016
24/09/2015 Centralised - Variation EMEA/H/C/2148/II/30
Updated with Decision(2016)231 of 14/01/2016
18/01/2016 Centralised - Renewal EMEA/H/C/2148/R/34 (2016)231 of 14/01/2016
23/03/2016 Centralised - Notification EMEA/H/C/2148/N/36
Updated with Decision(2017)1234 of 16/02/2017
08/12/2016 Centralised - Variation EMEA/H/C/2148/IAIN/41
Updated with Decision(2017)1234 of 16/02/2017
20/02/2017 PSUSA - Modification EMEA/H/C/2148/PSUSA/226/201605 (2017)1234 of 16/02/2017
19/10/2017 Centralised - Variation EMEA/H/C/2148/II/47
Updated with Decision(2018)3616 of 31/05/2018
17/05/2018 Centralised - Variation EMEA/H/C/2148/II/51
04/06/2018 Centralised - 2-Monthly update EMEA/H/C/2148/II/50 (2018)3616 of 31/05/2018