Renagel

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sevelamer

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 09/02/2018

Authorisation details

Product details
Name
Renagel
Agency product number
EMEA/H/C/000254
Active substance
sevelamer
International non-proprietary name (INN) or common name
sevelamer
Therapeutic area (MeSH)
  • Renal Dialysis
  • Hyperphosphatemia
Anatomical therapeutic chemical (ATC) code
V03AE02
Publication details
Marketing-authorisation holder
Genzyme Europe B.V.
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
28/01/2000
Contact address
Gooimer 10
NL-1411 DD Naarden
The Netherlands

Product information

15/12/2017 Renagel - EMEA/H/C/000254 - N/0108

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

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.

Assessment history

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