Renvela

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sevelamer carbonate

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

Overview

This is a summary of the European public assessment report (EPAR) for Renvela. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Renvela.

For practical information about using Renvela, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 05/10/2018

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 B.V.
Revision
16
Date of issue of marketing authorisation valid throughout the European Union
10/06/2009
Contact address
Gooimer 10
NL-1411 DD Naarden
The Netherlands

Product information

20/09/2018 Renvela - EMEA/H/C/000993 - X/0039

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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

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