Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva)

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sevelamer carbonate

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

Overview

Sevelamer carbonate Winthrop 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 Winthrop 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 19/11/2019

Authorisation details

Product details
Name
Sevelamer carbonate Winthrop (previously 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
16
Date of issue of marketing authorisation valid throughout the European Union
15/01/2015
Contact address

Paasheuvelweg 25
1105 BP Amsterdam
The Netherlands

Product information

11/11/2019 Sevelamer carbonate Winthrop (previously Sevelamer carbonate Zentiva) - EMEA/H/C/003971 - R/0022

Contents

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Pharmacotherapeutic group

ALL OTHER THERAPEUTIC PRODUCTS

Therapeutic indication

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

Sevelamer carbonate Winthrop 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 Winthrop 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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