Renvela
sevelamer carbonate
Table of contents
Overview
Renvela 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.
Renvela 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.
Authorisation details
Product details | |
---|---|
Name |
Renvela
|
Agency product number |
EMEA/H/C/000993
|
Active substance |
sevelamer carbonate
|
International non-proprietary name (INN) or common name |
sevelamer carbonate
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
V03AE02
|
Publication details | |
---|---|
Marketing-authorisation holder |
Genzyme Europe BV
|
Revision |
22
|
Date of issue of marketing authorisation valid throughout the European Union |
09/06/2009
|
Contact address |
Product information
12/11/2020 Renvela - EMEA/H/C/000993 - WS/1854
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
Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis.
Renvela 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.
Renvela 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.