Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Corlentor   
Auth. number : EU/1/05/317
INN : Ivabradine
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C01 - Cardiac therapy
Pharmacological subgroup: C01E - Other cardiac preparations
Chemical subgroup: C01EB - Other cardiac preparations
Chemical substance: C01EB17 - Ivabradine
(See WHO ATC Index)
Indication: Treatment of coronary artery disease
Symptomatic treatment of chronic stable angina pectoris in coronary artery disease adults with normal sinus rhythm. Ivabradine is indicated :
- in adults unable to tolerate or with a contra-indication to the use of beta-blockers
- or in combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.
Treatment of chronic heart failure
Ivabradine is indicated in chronic heart failure NYHA II to IV class with systolic dysfunction, in patients in sinus rhythm and whose heart rate is ≥ 75 bpm, in combination with standard therapy including beta-blocker therapy or when beta-blocker therapy is contraindicated or not tolerated.
Marketing Authorisation Holder: Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes CEDEX, France

  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
27/10/2005 Centralised - Authorisation EMEA/H/C/598 (2005)4265 of 25/10/2005
27/02/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/598/IA/1
07/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/598/IA/2
01/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/598/IA/4, 5
07/03/2007 Centralised - Variation EMEA/H/C/598/II/3 (2007)823 of 05/03/2007
23/03/2007 Centralised - Notification EMEA/H/C/598/N/6
Updated with Decision(2009)8392 of 23/10/2009
08/05/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/598/IA/9
23/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/598/II/8
07/05/2009 Centralised - Variation EMEA/H/C/598/II/11 (2009)3753 of 05/05/2009
24/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/598/IB/12
27/10/2009 Centralised - Variation EMEA/H/C/598/II/10 (2009)8392 of 23/10/2009
26/01/2010 Centralised - Variation EMEA/H/C/598/IB/14
Updated with Decision(2010)6092 of 31/08/2010
10/02/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/598/IA/13
24/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/598/IA/15
02/09/2010 Centralised - Renewal EMEA/H/C/598/R/16 (2010)6092 of 31/08/2010
02/12/2010 Centralised - Variation EMEA/H/C/598/II/17 (2010)8650 of 29/11/2010
11/03/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/598/IA/19
31/08/2011 Centralised - Variation EMEA/H/C/598/II/20 (2011)6234 of 26/08/2011
28/10/2011 Centralised - Variation EMEA/H/C/598/IA/21
Updated with Decision(2012)770 of 06/02/2012
08/02/2012 Centralised - Variation EMEA/H/C/598/II/18 (2012)770 of 06/02/2012
29/10/2012 Centralised - Variation EMEA/H/C/598/II/22 (2012)7705 of 25/10/2012
26/07/2013 Centralised - Notification EMEA/H/C/598/N/27
Updated with Decision(2013)9740 of 18/12/2013
23/12/2013 Centralised - 2-Monthly update (2013)9740 of 18/12/2013
26/08/2014 Centralised - Modification EMEA/H/C/598/PSUR/30 (2014)6082 of 22/08/2014
24/09/2014 Corrigendum (2014)6863 of 22/09/2014
07/11/2014 Centralised - Variation EMEA/H/C/598/IB/34/G