Tasermity
sevelamer hydrochloride
Table of contents
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.
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) |
|
Anatomical therapeutic chemical (ATC) code |
V03AE02
|
Publication details | |
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Marketing-authorisation holder |
Genzyme Europe BV
|
Revision |
4
|
Date of issue of marketing authorisation valid throughout the European Union |
25/02/2015
|
Contact address |
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
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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.