Tasermity

Lapsed

This medicine's authorisation has lapsed

sevelamer hydrochloride

Overview

On 26 February 2015, the marketing authorisation of Tasermity (sevelamer) ceased to be valid in the European Union (EU). The cessation of validity is due to the fact that the marketing authorisation holder, Genzyme Europe BV, had not marketed Tasermity in the EU since its initial marketing authorisation. 

In accordance with provisions of the sunset clause, the marketing authorisation of the medicinal product lapsed as the product had not been marketed in any of the EU Member States within three years of its initial authorisation. Tasermity was granted marketing authorisation in the EU on 26 February 2015 for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Tasermity is an identical product to Renagel, which remains authorised in the EU.

The European Public Assessment Report (EPAR) for Tasermity is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Tasermity : EPAR - Summary for the public

Reference Number: EMA/150836/2015

Product information

Tasermity : EPAR - Product Information

Tasermity : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Tasermity
• 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

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.

Authorisation details

• EMA product number:
  EMEA/H/C/003968
• Marketing authorisation holder:
  Genzyme Europe BV

  Paasheuvelweg 25; 1105 BP Amsterdam; The Netherlands

• Marketing authorisation issued:
  25/02/2015
• Lapse of marketing authorisation:
  26/02/2015
• Revision:
  4

Assessment history

Changes since initial authorisation of medicine

Tasermity : EPAR - Procedural steps taken and scientific information after authorisation

Tasermity-H-C-PSUSA-2697-201510 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number: EMA/CHMP/571186/2016

Initial marketing authorisation documents

Tasermity : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/68384/2015

CHMP summary of positive opinion for Tasermity

Adopted Reference Number: EMA/CHMP/761518/2014