Tasermity

RSS

sevelamer hydrochloride

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Tasermity has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.

This EPAR was last updated on 27/03/2018

Authorisation details

Product details
Name
Tasermity
Agency product number
EMEA/H/C/003968
Active substance
sevelamer hydrochloride
International non-proprietary name (INN) or common name
sevelamer hydrochloride
Therapeutic area (MeSH)
  • Hyperphosphatemia
  • Renal Dialysis
Anatomical therapeutic chemical (ATC) code
V03AE02
Publication details
Marketing-authorisation holder
Genzyme Europe BV
Revision
4
Date of issue of marketing authorisation valid throughout the European Union
26/02/2015
Contact address
Gooimeer 10
1411 DD Naarden
Netherlands

Product information

15/12/2017 Tasermity - EMEA/H/C/003968 - N/0006

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

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