Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Angiox   
Auth. number : EU/1/04/289
Active substance : Bivalirudin
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AE - Direct thrombin inhibitors
Chemical substance: B01AE06 - Bivalirudin
(See WHO ATC Index)
Indication: Angiox is indicated as an anticoagulant in adult patients undergoing percutaneous coronary intervention (PCI), including patients with ST-segment elevation myocardial infarction (STEMI) undergoing primary PCI.Angiox is also indicated for the treatment of adult patients with unstable angina/non-ST segment elevation myocardial infarction (UA/NSTEMI) planned for urgent or early intervention.Angiox should be administered with aspirin and clopidogrel.
Marketing Authorisation Holder: The Medicines Company UK Ltd
115L Milton Park, Abingdon, Oxfordshire OX14 4SA, 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
22/09/2004 Centralised - Authorisation EMEA/H/C/562 (2004)3578 of 20/09/2004
28/10/2004 Centralised - Variation EMEA/H/C/562/IB/1
Updated with Decision(2005)1802 of 10/06/2005
14/06/2005 Centralised - Variation (2005)1802 of 10/06/2005
24/08/2005 Centralised - Variation EMEA/H/C/562/IA/3
Updated with Decision(2006)876 of 15/03/2006
30/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IB/2
20/10/2005 Centralised - Variation EMEA/H/C/562/IB/4
Updated with Decision(2006)876 of 15/03/2006
17/03/2006 Centralised - Variation (2006)876 of 15/03/2006
08/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/II/5
07/09/2006 Centralised - Variation EMEA/H/C/562/II/6 (2006)4051 of 01/09/2006
12/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/9
25/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IB/11
12/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/10
09/03/2007 Centralised - Variation EMEA/H/C/562/II/7 (2007)842 of 07/03/2007
24/04/2007 Corrigendum EMEA/H/C/562/II/7 (2007)842 cor of 20/04/2007
10/07/2007 Centralised - Notification EMEA/H/C/562/N/12
Updated with Decision(2008)79 of 10/01/2008
11/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IB/13
14/01/2008 Centralised - Variation EMEA/H/C/562/II/8 (2008)79 of 10/01/2008
05/02/2008 Corrigendum (2008)79 cor of 01/02/2008
23/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/17
09/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/18
11/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/II/15
09/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/20
09/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/21
09/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/22
15/07/2008 Centralised - Variation EMEA/H/C/562/IA/19
Updated with Decision(2009)3132 of 21/04/2009
31/07/2008 Centralised - Variation EMEA/H/C/562/II/16 (2008)4168 of 29/07/2008
03/12/2008 Centralised - Variation EMEA/H/C/562/IA/23
Updated with Decision(2009)3132 of 21/04/2009
23/04/2009 Centralised - Variation (2009)3132 of 21/04/2009
22/06/2009 Centralised - Renewal EMEA/H/C/562/R/26 (2009)5046 of 18/06/2009
08/07/2009 Centralised - Variation EMEA/H/C/562/II/25 (2009)5476 of 02/07/2009
04/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/28
07/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/30
18/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/29
19/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/31
06/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/II/27
12/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/II/32
24/11/2009 Centralised - Variation EMEA/H/C/562/II/24 (2009)9344 of 20/11/2009
22/06/2010 Centralised - Variation EMEA/H/C/562/IA/33
Updated with Decision(2010)6112 of 31/08/2010
07/09/2010 Centralised - Variation (2010)6112 of 31/08/2010
15/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/34
04/02/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/35
28/02/2011 Centralised - Variation EMEA/H/C/562/IA/36
Updated with Decision(2011)6595 of 16/09/2011
08/08/2011 Centralised - Notification EMEA/H/C/562/N/39
Updated with Decision(2011)6595 of 16/09/2011
20/09/2011 Centralised - Variation (2011)6595 of 16/09/2011
14/11/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/562/IA/40/G
23/02/2012 Centralised - Variation EMEA/H/C/562/II/37 (2012)1270 of 21/02/2012
31/05/2012 Referral EMEA/H/C/562/A-20/42 (2012)3587 of 25/05/2012
16/11/2012 Centralised - Variation EMEA/H/C/562/II/47
Updated with Decision(2013)8343 of 20/11/2013
22/11/2013 Centralised - Yearly update (2013)8343 of 20/11/2013
20/03/2014 Centralised - Variation EMEA/H/C/562/II/50
Updated with Decision(2014)4361 of 23/06/2014
25/06/2014 Centralised - Renewal EMEA/H/C/562/R/52 (2014)4361 of 23/06/2014
09/02/2015 Centralised - Notification EMEA/H/C/562/N/59
Updated with Decision(2015)9649 of 16/12/2015
24/09/2015 Centralised - Variation EMEA/H/C/562/II/58
Updated with Decision(2015)9649 of 16/12/2015
18/12/2015 Centralised - 2-Monthly update EMEA/H/C/562/II/62 (2015)9649 of 16/12/2015
04/04/2016 Rectificative Decision (2016)2025 of 31/03/2016