Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Integrilin   
Auth. number : EU/1/99/109
INN : Eptifibatide
ATC: Anatomical main group: B - Blood and blood forming organs
Therapeutic subgroup: B01 - Antithrombotic agents
Pharmacological subgroup: B01A - Antithrombotic agents
Chemical subgroup: B01AC - Platelet aggregation inhibitors excluding Heparin
Chemical substance: B01AC16 - Eptifibatide
(See WHO ATC Index)
Indication: INTEGRILIN is intended for use with acetylsalicylic acid and unfractionated heparin.INTEGRILIN is indicated for the prevention of early myocardial infarction in adults presenting with unstable angina or non-Q-wave myocardial infarction, with the last episode of chest pain occurring within 24 hours and with electrocardiogram (ECG) changes and/or elevated cardiac enzymes.Patients most likely to benefit from INTEGRILIN treatment are those at high risk of developing myocardial infarction within the first 3-4 days after onset of acute angina symptoms including for instance those that are likely to undergo an early PTCA (Percutaneous Transluminal Coronary Angioplasty)
Marketing Authorisation Holder: Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, 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
09/07/1999 Centralised - Authorisation EMEA/H/C/230 (1999)1901 of 01/07/1999
22/09/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/I/1-6
06/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/I/8, 10
31/07/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/I/7
17/12/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/II/16
07/02/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/II/12
23/04/2002 Centralised - Variation EMEA/H/C/230/II/17 (2002)1573 of 19/04/2002
05/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/I/19
07/10/2002 Centralised - Variation EMEA/H/C/230/II/18 (2002)3716 of 03/10/2002
26/03/2003 Centralised - Notification EMEA/H/C/230/N/21 (2003)1035 of 24/03/2003
28/04/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/I/22
18/09/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/I/23
26/02/2004 Centralised - Variation EMEA/H/C/230/II/24 (2004)629 of 23/02/2004
27/05/2004 Centralised - Notification EMEA/H/C/230/N/27
Updated with Decision(2004)3425 of 02/09/2004
11/08/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/II/26
06/09/2004 Centralised - Renewal EMEA/H/C/230/R/25 (2004)3425 of 02/09/2004
05/10/2004 Centralised - Variation EMEA/H/C/230/IA/29
Updated with Decision(2004)4843 of 06/12/2004
05/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/IA/28
08/12/2004 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/230/T/30 (2004)4843 of 06/12/2004
13/12/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/IA/31
29/07/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/II/32
23/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/II/33
07/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/IA/35
21/11/2005 Centralised - Variation EMEA/H/C/230/II/34 (2005)4529 of 17/11/2005
27/04/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/IB/36
27/09/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/II/38
05/03/2007 Centralised - Variation EMEA/H/C/230/II/39 (2007)764 of 01/03/2007
25/06/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/II/37
01/08/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/IA/40
05/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/II/42
09/04/2009 Centralised - Variation EMEA/H/C/230/II/45 (2009)2874 of 07/04/2009
02/07/2009 Centralised - Renewal EMEA/H/C/230/R/44 (2009)5406 of 01/07/2009
30/10/2009 Centralised - Variation EMEA/H/C/230/II/46 (2009)8510 of 28/10/2009
17/11/2009 Centralised - Variation EMEA/H/C/230/IA/48
Updated with Decision(2010)367 of 20/01/2010
22/01/2010 Centralised - Variation EMEA/H/C/230/II/47 (2010)367 of 20/01/2010
26/05/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/230/IA/50
25/01/2011 Centralised - Variation EMEA/H/C/230/IG/34/G
Updated with Decision(2011)2801 of 14/04/2011
20/04/2011 Centralised - Variation EMEA/H/C/230/II/49 (2011)2801 of 14/04/2011
01/08/2011 Centralised - Variation EMEA/H/C/230/II/51 (2011)5594 of 27/07/2011
16/01/2012 Centralised - Variation EMEA/H/C/230/IB/53
Updated with Decision(2012)2024 of 21/03/2012
23/03/2012 Centralised - Variation EMEA/H/C/230/II/56 (2012)2024 of 21/03/2012
10/05/2012 Centralised - Notification EMEA/H/C/230/N/62
Updated with Decision(2014)2830 of 23/04/2014
18/04/2013 Centralised - Variation EMEA/H/C/230/IG/279
Updated with Decision(2014)2830 of 23/04/2014
07/11/2013 Centralised - Notification EMEA/H/C/230/N/66
Updated with Decision(2014)2830 of 23/04/2014
25/04/2014 Centralised - Yearly update (2014)2830 of 23/04/2014