Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Cholestagel   
Auth. number : EU/1/03/268
INN : colesevelam hydrochloride
ATC: Anatomical main group: C - Cardiovascular system
Therapeutic subgroup: C10 - Lipid modifying agents
Pharmacological subgroup: C10A - Lipid modifying agents, plain
Chemical subgroup: C10AC - Bile acid sequestrants
Chemical substance: C10AC04 - Colesevelam
(See WHO ATC Index)
Indication: adjunctive therapy to diet to provide an additive reduction in LDL-cholesterol levels in patients with primary hypercholesterolaemia
Marketing Authorisation Holder: Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland

  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
12/03/2004 Centralised - Authorisation EMEA/H/C/512 (2004)856 of 10/03/2004
16/06/2005 Centralised - Variation EMEA/H/C/512/N/1
Updated with Decision(2008)954 of 05/03/2008
14/05/2007 Centralised - Variation EMEA/H/C/512/IB/3
Updated with Decision(2008)954 of 05/03/2008
26/06/2007 Centralised - Variation EMEA/H/C/512/II/2
03/08/2007 Centralised - Variation EMEA/H/C/512/IA/4
12/10/2007 Centralised - Variation EMEA/H/C/512/IA/5
05/02/2008 Centralised - Variation EMEA/H/C/512/IA/9
Updated with Decision(2008)3089 of 19/06/2008
07/03/2008 Centralised - Variation (2008)954 of 05/03/2008
23/06/2008 Centralised - Variation EMEA/H/C/512/II/7 (2008)3089 of 19/06/2008
11/07/2008 Centralised - Variation EMEA/H/C/512/II/8 (2008)3618 of 09/07/2008
28/10/2008 Centralised - Variation EMEA/H/C/512/II/11
24/12/2008 Centralised - Variation EMEA/H/C/512/II/10 (2008)8973 of 22/12/2008
01/04/2009 Centralised - Renewal EMEA/H/C/512/R/12 (2009)2557 of 30/03/2009
02/04/2009 Centralised - Variation EMEA/H/C/512/N/13
Updated with Decision(2011)5946 of 10/08/2011
25/03/2010 Centralised - Variation EMEA/H/C/512/II/15, 14 (2010)2008 of 23/03/2010
10/05/2010 Centralised - Variation EMEA/H/C/512/IA/17
11/05/2010 Centralised - Variation EMEA/H/C/512/IA/18
26/05/2010 Centralised - Variation EMEA/H/C/512/IB/16
01/06/2010 Centralised - Variation EMEA/H/C/512/IA/19
08/07/2010 Centralised - Variation EMEA/H/C/512/IB/20
07/10/2010 Centralised - Variation EMEA/H/C/512/N/21
Updated with Decision(2012)1275 of 21/02/2012
28/03/2011 Centralised - Variation EMEA/H/C/512/IA/22
12/08/2011 Centralised - Variation EMEA/H/C/512/II/14,15 (2011)5946 of 10/08/2011
28/09/2011 Centralised - Variation EMEA/H/C/512/IA/23
Updated with Decision(2012)1275 of 21/02/2012
24/02/2012 Centralised - Variation EMEA/H/C/512/II/24 (2012)1275 of 21/02/2012
23/07/2012 Centralised - Variation EMEA/H/C/512/N/26
20/08/2013 Centralised - Variation EMEA/H/C/512/N/28
25/11/2013 Centralised - Variation EMEA/H/C/512/N/29