Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Renvela   
Auth. number : EU/1/09/521
INN : sevelamer (carbonate)
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: Control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/l.
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
12/06/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/993 (2009)4620 of 10/06/2009
12/06/2009 Centralised - Authorisation EMEA/H/C/993 (2009)4621 of 10/06/2009
08/07/2009 Centralised - Variation EMEA/H/C/993/IB/1
31/07/2009 Centralised - Variation EMEA/H/C/993/IB/2
Updated with Decision(2010)1951 of 19/03/2010
27/08/2009 Centralised - Variation EMEA/H/C/993/IA/4
02/09/2009 Centralised - Variation EMEA/H/C/993/IB/3
05/10/2009 Centralised - Variation EMEA/H/C/993/IB/5
27/11/2009 Centralised - Variation EMEA/H/C/993/IB/6
23/03/2010 Centralised - Variation (2010)1951 of 19/03/2010
11/05/2010 Centralised - Variation EMEA/H/C/993/IA/8
11/05/2010 Centralised - Variation EMEA/H/C/993/IA/7
09/09/2010 Centralised - Variation EMEA/H/C/993/II/9 (2010)6249 of 06/09/2010
10/11/2011 Centralised - Variation EMEA/H/C/993/IG/116
Updated with Decision(2011)10115 of 22/12/2011
27/12/2011 Centralised - Variation EMEA/H/C/993/WS/188 (2011)10115 of 22/12/2011
13/04/2012 Centralised - Variation EMEA/H/C/993/N/18
Updated with Decision(2014)2055 of 21/03/2014
31/08/2012 Centralised - Variation EMEA/H/C/993/N/21
Updated with Decision(2014)2055 of 21/03/2014
22/10/2013 Centralised - Variation EMEA/H/C/993/N/26
Updated with Decision(2014)2055 of 21/03/2014
26/03/2014 Centralised - Renewal EMEA/H/C/993/R/27 (2014)2055 of 21/03/2014