sevelamer carbonate

This medicine is authorised for use in the European Union.


Renvela is a medicine used to control hyperphosphataemia (high blood phosphate levels) in:

  • adult patients on dialysis (a technique to remove unwanted substances from the blood);
  • adults and children from 6 years of age with chronic (long term) kidney disease.

Renvela should be used with other treatments such as calcium supplements and vitamin D to prevent the development of bone disease. It contains the active substance sevelamer carbonate.

This EPAR was last updated on 02/12/2020

Authorisation details

Product details
Agency product number
Active substance
sevelamer carbonate
International non-proprietary name (INN) or common name
sevelamer carbonate
Therapeutic area (MeSH)
  • Hyperphosphatemia
  • Renal Dialysis
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Genzyme Europe BV
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

12/11/2020 Renvela - EMEA/H/C/000993 - WS/1854


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Pharmacotherapeutic group

All other therapeutic products

Therapeutic indication

Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.

Renvela is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus ≥ 1.78 mmol/l.

Renvela should be used within the context of a multiple therapeutic approach, which could include calcium supplement, 1,25-dihydroxy vitamin D3 or one of its analogues to control the development of renal bone disease.

Assessment history

Changes since initial authorisation of medicine

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