Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Xarelto   
Auth. number : EU/1/08/472
INN : rivaroxaban
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AX - Other antithrombotic agents
Chemical substance: B01AX06 - Rivaroxaban
(See WHO ATC Index)
Indication: 2.5 mg: Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers.
10 mg: Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery.
15 mg et 20 mg: Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.
Marketing Authorisation Holder: Bayer Pharma AG
D-13342 Berlin, Deutschland

  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
02/10/2008 Centralised - Authorisation EMEA/H/C/944 (2008)5680 of 30/09/2008
10/03/2009 Centralised - Variation EMEA/H/C/944/IA/2
Updated with Decision(2009)2701 of 02/04/2009
06/04/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/944/T/1 (2009)2701 of 02/04/2009
23/10/2009 Centralised - Variation EMEA/H/C/944/II/3 (2009)8317 of 21/10/2009
26/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/944/IA/4
29/04/2010 Centralised - Notification EMEA/H/C/944/N/5
Updated with Decision(2010)7215 of 14/10/2010
27/05/2010 Centralised - Variation EMEA/H/C/944/IA/6/G
Updated with Decision(2010)7215 of 14/10/2010
21/06/2010 Centralised - Variation EMEA/H/C/944/IG/9/G
Updated with Decision(2010)7215 of 14/10/2010
18/10/2010 Centralised - Variation (2010)7215 of 14/10/2010
04/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/944/IA/8/G
19/11/2010 Centralised - Notification EMEA/H/C/944/N/9
Updated with Decision(2011)466 of 24/01/2011
12/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/944/IA/11/G
27/01/2011 Centralised - Variation EMEA/H/C/944/II/7 (2011)466 of 24/01/2011
15/04/2011 Centralised - Variation EMEA/H/C/944/IB/13/G
Updated with Decision(2011)9437 of 09/12/2011
23/08/2011 Centralised - Variation EMEA/H/C/944/IA/14/G
Updated with Decision(2011)9437 of 09/12/2011
19/12/2011 Centralised - Variation EMEA/H/C/944/X/10 & EMEA/H/C/944/II-12 (2011)9758 of 14/12/2011
20/12/2011 Centralised - Variation EMEA/H/C/944/X/10 & EMEA/H/C/944/II-12 (2011)9437 of 09/12/2011
31/05/2012 Centralised - Variation EMEA/H/C/944/II/16/G (2012)3610 of 25/05/2012
07/06/2012 Centralised - Variation EMEA/H/C/944/IB/20/G
Updated with Decision(2012)7876 of 29/10/2012
31/10/2012 Centralised - Variation (2012)7876 of 29/10/2012
19/11/2012 Centralised - Variation EMEA/H/C/944/II/18 (2012)8484 of 15/11/2012
28/11/2012 Centralised - Variation EMEA/H/C/944/IAin/21/G
Updated with Decision(2013)3109 of 22/05/2013
24/05/2013 Centralised - Renewal EMEA/H/C/944/R/22, EMEA/H/C/944/X/17 (2013)3109 of 22/05/2013
08/08/2013 Centralised - 2-Monthly update EMEA/H/C/944/II/23 (2013)5293 of 05/08/2013
07/11/2013 Centralised - Variation EMEA/H/C/944/IAin/25/G
Updated with Decision(2014)5626 of 31/07/2014
21/11/2013 Centralised - Variation EMEA/H/C/944/II/24/G
Updated with Decision(2014)5626 of 31/07/2014
22/04/2014 Centralised - Notification EMEA/H/C/944/N/28
Updated with Decision(2014)5626 of 31/07/2014
05/06/2014 Centralised - Notification EMEA/H/C/944/N/29
Updated with Decision(2014)5626 of 31/07/2014
24/07/2014 Centralised - Variation EMEA/H/C/944/II/31
04/08/2014 Centralised - 2-Monthly update EMEA/H/C/944/II/30 (2014)5626 of 31/07/2014