Tasermity

sevelamer hydrochloride

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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.

Name Language First published Last updated
Tasermity : EPAR - Summary for the public BG = bălgarski 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public ES = español 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public CS = čeština 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public DA = dansk 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public DE = Deutsch 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public ET = eesti keel 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public EL = elliniká 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public EN = English 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public FR = français 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public IT = italiano 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public LV = latviešu valoda 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public LT = lietuvių kalba 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public HU = magyar 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public MT = Malti 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public NL = Nederlands 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public PL = polski 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public PT = português 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public RO = română 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public SK = slovenčina 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public SL = slovenščina 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public FI = suomi 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public SV = svenska 2015-04-09 2018-03-27
Tasermity : EPAR - Summary for the public HR = Hrvatski 2015-04-09 2018-03-27

This EPAR was last updated on 27/03/2018 .

Authorisation details

Product details

Product details for Tasermity
NameTasermity
Agency product numberEMEA/H/C/003968
Active substance

sevelamer hydrochloride

International non-proprietary name (INN) or common name

sevelamer hydrochloride

Therapeutic area HyperphosphatemiaRenal Dialysis
Anatomical therapeutic chemical (ATC) code V03AE02

Publication details

Publication details for Tasermity
Marketing-authorisation holder

Genzyme Europe BV

Revision4
Date of issue of marketing authorisation valid throughout the European Union26/02/2015

Contact address:

Genzyme Europe BV
Gooimeer 10
1411 DD Naarden
Netherlands

Product information

Product information

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

Name Language First published Last updated
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - Product Information HR = Hrvatski 2015-04-09 2018-03-27

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.


Name Language First published Last updated
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27
Tasermity : EPAR - All Authorised presentations HR = Hrvatski 2015-04-09 2018-03-27

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

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Tasermity : EPAR - Public assessment report HR = Hrvatski 2015-04-09 2018-03-27
CHMP summary of positive opinion for Tasermity HR = Hrvatski 2014-12-19 2018-03-27

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Tasermity