Sevelamer carbonate Zentiva

RSS

sevelamer carbonate

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

Overview

Sevelamer carbonate Zentiva 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.

Sevelamer carbonate Zentiva 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 09/10/2018

Authorisation details

Product details
Name
Sevelamer carbonate Zentiva
Agency product number
EMEA/H/C/003971
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
11
Date of issue of marketing authorisation valid throughout the European Union
14/01/2015
Contact address
Gooimeer 10
1411 DD Naarden
The Netherlands

Product information

19/09/2018 Sevelamer carbonate Zentiva - EMEA/H/C/003971 - X/0011

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

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

Sevelamer carbonate Zentiva 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.

Sevelamer carbonate Zentiva 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

How useful was this page?

Add your rating