Renvela

sevelamer carbonate

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This is a summary of the European public assessment report (EPAR) for Renvela. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Renvela.

For practical information about using Renvela, patients should read the package leaflet or contact their doctor or pharmacist.

What is Renvela and what is it used for?

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.

How is Renvela used?

Renvela is available as tablets (800 mg) and as powder (1.6 g and 2.4 g) in a sachet to be taken three times a day with meals.

The dose to take depends on the patient’s level of blood phosphate and, in case of children, their height and weight. Renvela must not be taken on an empty stomach and patients should keep to their prescribed diets.

The medicine can only be obtained with a prescription.

For further information, see the package leaflet.

How does Renvela work?

The active substance in Renvela, sevelamer carbonate, is a phosphate binder. When taken with meals, it attaches in the gut to phosphate from food, thereby preventing the phosphate from being absorbed into the body and helping reduce phosphate levels in the blood.

What benefits of Renvela have been shown in studies?

Renvela has been shown in studies to be effective at lowering levels of blood phosphate in patients with hyperphosphataemia.

In two main studies in 110 adults with kidney disease who were on dialysis, Renvela brought phosphate levels down to around 1.5-1.6 mmol/l (which is within or close to the normal range) and was as effective as another approved medicine Renagel.

In a third main study in 49 adults who were not on dialysis, Renvela reduced phosphate levels from 2.0 mmol/l to 1.6 mmol/l.

Finally, a main study also showed that Renvela was effective at lowering phosphate levels in 100 children: children who took Renvela had a greater reduction in phosphorous (0.87 mg/dl) than those taking placebo (a dummy treatment) who had a rise in phosphorous of 0.04 mg/dl.

What are the risks associated with Renvela?

The most common side effects with Renvela (seen in more than 1 patient in 10) are nausea (feeling sick), vomiting, upper abdominal (belly) pain and constipation. For the full list of all side effects reported with Renvela, see the package leaflet.
Renvela must not be used in people with low blood phosphate levels or with bowel obstruction (a blockage in the gut). For the full list of restrictions, see the package leaflet.

Why is Renvela approved?

Studies show that Renvela is effective at reducing levels of blood phosphate in patients with hyperphosphataemia, and its side effects are considered manageable. The European Medicines Agency therefore concluded that Renvela’s benefits are greater than its risks and recommended that it be approved for use in the EU.

What measures are being taken to ensure the safe and effective use of Renvela?

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Renvela have been included in the summary of product characteristics and the package leaflet.

Other information about Renvela

The European Commission granted a marketing authorisation valid throughout the European Union for Renvela on 10 June 2009.

For more information about treatment with Renvela, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Renvela : EPAR - Summary for the public BG = bălgarski 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public ES = español 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public CS = čeština 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public DA = dansk 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public DE = Deutsch 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public ET = eesti keel 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public EL = elliniká 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public EN = English 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public FR = français 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public IT = italiano 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public LV = latviešu valoda 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public LT = lietuvių kalba 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public HU = magyar 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public MT = Malti 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public NL = Nederlands 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public PL = polski 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public PT = português 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public RO = română 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public SK = slovenčina 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public SL = slovenščina 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public FI = suomi 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public SV = svenska 2009-06-23 2017-07-26
Renvela : EPAR - Summary for the public HR = Hrvatski 2009-06-23 2017-07-26

This EPAR was last updated on 26/10/2017 .

Authorisation details

Product details

Product details for Renvela
NameRenvela
Agency product numberEMEA/H/C/000993
Active substance

sevelamer carbonate

International non-proprietary name (INN) or common name

sevelamer carbonate

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

Publication details

Publication details for Renvela
Marketing-authorisation holder

Genzyme Europe B.V.

Revision13
Date of issue of marketing authorisation valid throughout the European Union10/06/2009

Contact address:

Genzyme Europe B.V.
Gooimer 10
NL-1411 DD Naarden
The Netherlands

Product information

Product information

22/09/2017  Renvela -EMEA/H/C/000993 -IG/844

Name Language First published Last updated
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26
Renvela : EPAR - Product Information HR = Hrvatski 2009-08-13 2017-10-26

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
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  
Renvela : EPAR - All Authorised presentations HR = Hrvatski 2009-06-23  

Name Language First published Last updated
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  
Renvela : EPAR - Conditions imposed on member states for safe and effective use - Annex IV HR = Hrvatski 2009-06-23  

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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Renvela : EPAR - Public assessment report HR = Hrvatski 2009-06-23  
Committee for medicinal products for human use, summary of positive opinion for Renvela HR = Hrvatski 2009-03-19  

Authorised

This medicine is approved for use in the European Union

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