Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Procoralan   
Auth. number : EU/1/05/316
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 diseaseSymptomatic 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 failureIvabradine 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/597 (2005)4268 of 25/10/2005
20/12/2005 Corrigendum EMEA/H/C/597
27/02/2006 Centralised - Variation EMEA/H/C/597/IA/1
07/03/2006 Centralised - Variation EMEA/H/C/597/IA/2
01/12/2006 Centralised - Variation EMEA/H/C/597/IA/4, 5
08/03/2007 Centralised - Variation EMEA/H/C/597/II/3 (2007)830 of 06/03/2007
08/05/2008 Centralised - Variation EMEA/H/C/597/IA/8
23/07/2008 Centralised - Variation EMEA/H/C/597/II/7
24/07/2008 Centralised - Variation EMEA/H/C/597/IA/9
Updated with Decision(2009)2470 of 27/03/2009
01/04/2009 Centralised - Variation (2009)2470 of 27/03/2009
07/05/2009 Centralised - Variation EMEA/H/C/597/II/11 (2009)3754 of 05/05/2009
24/08/2009 Centralised - Variation EMEA/H/C/597/IB/12
27/10/2009 Centralised - Variation EMEA/H/C/597/II/10 (2009)8398 of 23/10/2009
26/01/2010 Centralised - Variation EMEA/H/C/597/IB/14
Updated with Decision(2010)6093 of 31/08/2010
10/02/2010 Centralised - Variation EMEA/H/C/597/IA/13
24/03/2010 Centralised - Variation EMEA/H/C/597/IA/15
02/09/2010 Centralised - Renewal EMEA/H/C/598/R/16 (2010)6093 of 31/08/2010
02/12/2010 Centralised - Variation EMEA/H/C/597/II/17 (2010)8652 of 29/11/2010
11/03/2011 Centralised - Variation EMEA/H/C/597/IA/19
31/08/2011 Centralised - Variation EMEA/H/C/597/II/20 (2011)6235 of 26/08/2011
21/10/2011 Centralised - Variation EMEA/H/C/597/IA/22
Updated with Decision(2012)890 of 09/02/2012
28/10/2011 Centralised - Variation EMEA/H/C/597/IA/21
Updated with Decision(2012)890 of 09/02/2012
13/02/2012 Centralised - Variation EMEA/H/C/597/II/18 (2012)890 of 09/02/2012
04/07/2012 Corrigendum (2012)4590 of 28/06/2012
29/10/2012 Centralised - Variation EMEA/H/C/597/II/23 (2012)7704 of 25/10/2012
13/03/2013 Centralised - Variation EMEA/H/C/597/IAin/27/G
Updated with Decision(2013)9741 of 18/12/2013
26/07/2013 Centralised - Variation EMEA/H/C/597/N/28
Updated with Decision(2013)9741 of 18/12/2013
23/12/2013 Centralised - Variation EMEA/H/C/597/II/29 (2013)9741 of 18/12/2013
26/08/2014 Centralised - Modification EMEA/H/C/597/PSUR/31 (2014)6083 of 22/08/2014