Renvela

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sevelamer carbonate

Authorised
This medicine is authorised for use in the European Union.

Overview

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 03/09/2019

Authorisation details

Product details
Name
Renvela
Agency product number
EMEA/H/C/000993
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
V03AE02
Publication details
Marketing-authorisation holder
Genzyme Europe BV
Revision
20
Date of issue of marketing authorisation valid throughout the European Union
09/06/2009
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

26/08/2019 Renvela - EMEA/H/C/000993 - PSUSA/00002697/201810

Contents

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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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