Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Eliquis   
Auth. number : EU/1/11/691
INN : 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 - Variation 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 - Variation EMEA/H/C/2148/N/13
Updated with Decision(2013)8164 of 15/11/2013
29/08/2013 Centralised - 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
25/04/2014 Centralised - Variation EMEA/H/C/2148/II/16
25/04/2014 Centralised - Variation EMEA/H/C/2148/II/17
12/06/2014 Centralised - Variation EMEA/H/C/2148/N/20