Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Renagel   
Auth. number : EU/1/99/123
INN : Sevelamer
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AE - Drugs for treatment of hyperkalemia and hyperphosphatemia
Chemical substance: V03AE02 - Sevelamer
(See WHO ATC Index)
Indication: Renagel is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renagel should be used within the context of a multiple therapeutic approach, which could include calcium supplements, 1,25 – dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.
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
02/02/2000 Centralised - Authorisation EMEA/H/C/254 (2000)119 of 28/01/2000
12/05/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/1
21/09/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/2
25/04/2001 Centralised - Authorisation EMEA/H/C/254 (2001)838 of 23/04/2001
10/08/2001 Centralised - Variation EMEA/H/C/254/II/6 (2001)2096 of 09/08/2001
16/10/2001 Centralised - Variation EMEA/H/C/254/I/8 (2001)2835 of 15/10/2001
07/11/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/9
17/01/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/10
08/02/2002 Centralised - Annual reassessment EMEA/H/C/254/S/7 (2002)495 of 06/02/2002
22/02/2002 Centralised - Variation EMEA/H/C/254/I/11 (2002)628 of 19/02/2002
11/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/15
30/07/2002 Centralised - Annual reassessment EMEA/H/C/254/S/13 (2002)2991 of 26/07/2002
09/10/2002 Centralised - Notification EMEA/H/C/254/N/16 (2002)3789 of 07/10/2002
14/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/14
15/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/18
06/03/2003 Centralised - Variation EMEA/H/C/254/II/17 (2003)757 of 04/03/2003
11/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/19
31/03/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/22
24/04/2003 Centralised - Variation EMEA/H/C/254/I/21 (2003)1399 of 22/04/2003
27/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/26
16/07/2003 Centralised - Annual reassessment EMEA/H/C/254/S/23 (2003)2622 of 14/07/2003
19/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/27, 28
19/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/24, 25
19/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/32
25/08/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/30
15/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/33
22/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/I/35
29/01/2004 Centralised - Variation EMEA/H/C/254/II/29 (2004)238 of 27/01/2004
31/03/2004 Centralised - Annual reassessment EMEA/H/C/254/S/38
04/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/39
10/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/41
29/06/2004 Centralised - Variation EMEA/H/C/254/IB/40
Updated with Decision(2005)245 of 26/01/2005
30/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/43
24/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/II/44
12/01/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/45
28/01/2005 Centralised - Renewal EMEA/H/C/254/R/42 (2005)245 of 26/01/2005
09/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IB/47
27/04/2005 Centralised - Annual reassessment EMEA/H/C/254/S/46
01/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/II/48
05/09/2005 Centralised - Variation EMEA/H/C/254/II/49 (2005)3394 of 31/08/2005
12/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/50
03/10/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/51
02/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/53
13/12/2005 Centralised - Notification EMEA/H/C/254/N/52
Updated with Decision(2006)3001 of 26/06/2006
16/01/2006 Centralised - Notification EMEA/H/C/254/N/54
Updated with Decision(2006)3001 of 26/06/2006
28/06/2006 Centralised - Annual reassessment EMEA/H/C/254/S/55 (2006)3001 of 26/06/2006
31/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/57
14/12/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/59
01/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IB/60
23/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IB/61
20/03/2007 Centralised - Variation EMEA/H/C/254/IA/62
Updated with Decision(2007)2425 of 01/06/2007
28/03/2007 Centralised - Variation EMEA/H/C/254/IA/63
Updated with Decision(2007)2425 of 01/06/2007
29/03/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/64
05/06/2007 Centralised - Variation EMEA/H/C/254/II/56 (2007)2425 of 01/06/2007
19/03/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/68
07/04/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/69
20/06/2008 Centralised - Variation EMEA/H/C/254/II/65, 66 (2008)3073 of 18/06/2008
09/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/71
09/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/73
15/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/72
18/08/2008 Centralised - Variation EMEA/H/C/254/IB/70
Updated with Decision(2009)3129 of 21/04/2009
29/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IB/75
22/12/2008 Centralised - Variation EMEA/H/C/254/IA/77
Updated with Decision(2009)3129 of 21/04/2009
18/02/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/79
23/04/2009 Centralised - Variation (2009)3129 of 21/04/2009
04/05/2009 Centralised - Variation EMEA/H/C/254/IB/80
Updated with Decision(2009)6116 of 27/07/2009
22/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/83
24/06/2009 Centralised - Notification EMEA/H/C/254/N/81
Updated with Decision(2009)6116 of 27/07/2009
29/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IB/85
30/07/2009 Centralised - Variation EMEA/H/C/254/II/78 (2009)6116 of 27/07/2009
27/08/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IB/82
06/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/86
26/11/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/254/IA/88
10/12/2009 Centralised - Renewal EMEA/H/C/254/R/84 (2009)10057 of 08/12/2009
07/06/2010 Centralised - Variation EMEA/H/C/254/II/87 (2010)3670 of 02/06/2010
26/11/2010 Centralised - Variation EMEA/H/C/254/IA/89
Updated with Decision(2011)1153 of 18/02/2011
22/02/2011 Centralised - Variation (2011)1153 of 18/02/2011
27/12/2011 Centralised - Variation EMEA/H/C/254/II/WS/188 (2011)10094 of 22/12/2011
14/04/2012 Centralised - Notification EMEA/H/C/254/N/91
01/09/2012 Centralised - Notification EMEA/H/C/254/N/92
22/10/2013 Centralised - Notification EMEA/H/C/254/N/96