Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ranexa   
Auth. number : EU/1/08/462
INN : ranolazine
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: C01EB18 - Ranolazine
(See WHO ATC Index)
Indication: Therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line antianginal therapies (such as beta-blockers and/or calcium antagonists).
Marketing Authorisation Holder: Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg

  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
10/07/2008 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/805 (2008)3623 of 09/07/2008
14/07/2008 Centralised - Authorisation EMEA/H/C/805 (2008)3622 of 09/07/2008
15/09/2008 Centralised - Variation EMEA/H/C/805/IB/1
Updated with Decision(2009)1429 of 25/02/2009
07/11/2008 Centralised - Variation EMEA/H/C/805/IB/5
Updated with Decision(2009)1429 of 25/02/2009
07/11/2008 Centralised - Variation EMEA/H/C/805/IB/6
Updated with Decision(2009)1429 of 25/02/2009
07/11/2008 Centralised - Variation EMEA/H/C/805/IB/4
Updated with Decision(2009)1429 of 25/02/2009
07/11/2008 Centralised - Variation EMEA/H/C/805/IB/3
Updated with Decision(2009)1429 of 25/02/2009
07/11/2008 Centralised - Variation EMEA/H/C/805/IB/2
Updated with Decision(2009)1429 of 25/02/2009
07/11/2008 Centralised - Variation EMEA/H/C/805/IB/7
Updated with Decision(2009)1429 of 25/02/2009
26/02/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/805/T/8 (2009)1430 of 25/02/2009
27/02/2009 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/805/T/8 (2009)1429 of 25/02/2009
07/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/805/IA/12
07/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/805/IA/15
15/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/805/IA/10
14/05/2009 Centralised - Variation EMEA/H/C/805/IA/16
Updated with Decision(2009)6662 of 25/08/2009
14/05/2009 Centralised - Variation EMEA/H/C/805/IA/15
Updated with Decision(2009)6662 of 25/08/2009
14/05/2009 Centralised - Variation EMEA/H/C/805/IA/17
Updated with Decision(2009)6662 of 25/08/2009
14/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/805/IA/9
15/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/805/IB/13
27/08/2009 Centralised - Variation EMEA/H/C/805/IB/II/18, 19, 20 (2009)6662 of 25/08/2009
15/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/805/IB/21
15/12/2009 Centralised - Variation EMEA/H/C/805/IB/22
Updated with Decision(2010)3173 of 10/05/2010
13/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/805/IA/24
12/05/2010 Centralised - Variation EMEA/H/C/805/II/23 (2010)3173 of 10/05/2010
12/05/2010 Centralised - Variation EMEA/H/C/805/II/23 (2010)3172 of 10/05/2010
16/07/2010 Centralised - Variation EMEA/H/C/805/IB/25/G
Updated with Decision(2011)566 of 27/01/2011
25/11/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/805//II/26
01/02/2011 Centralised - Variation (2011)566 of 27/01/2011
25/02/2011 Centralised - Variation EMEA/H/C/805/II/28 (2011)1229 of 21/02/2011
21/06/2011 Centralised - Variation EMEA/H/C/805/II/29 (2011)4458 of 17/06/2011
22/03/2012 Centralised - Variation EMEA/H/C/805/II/30 (2012)1940 of 19/03/2012
13/04/2012 Centralised - Variation EMEA/H/C/805/IB/33
Updated with Decision(2012)7770 of 25/10/2012
15/10/2012 Centralised - Variation EMEA/H/C/805/IA/39
Updated with Decision(2012)7911 of 29/10/2012
12/11/2012 Centralised - Variation (2012)7770 of 25/10/2012
14/11/2012 Centralised - Variation (2012)7911 of 29/10/2012
08/03/2013 Centralised - Renewal EMEA/H/C/805/R/40 (2013)1420 of 06/03/2013
03/04/2013 Centralised - Variation EMEA/H/C/805/IAin/41/G
Updated with Decision(2013)8075 of 13/11/2013
25/04/2013 Centralised - Variation EMEA/H/C/805/II/38
Updated with Decision(2013)8075 of 13/11/2013
09/10/2013 Centralised - Notification EMEA/H/C/805/N/42
22/11/2013 Centralised - Maintain EMEA/H/C/805/PSU/18 (2013)8075 of 13/11/2013
06/08/2014 Centralised - Variation EMEA/H/C/805/IAin/47/G