BindRen

RSS

colestilan

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for BindRen has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 01/04/2015

Authorisation details

Product details
Name
BindRen
Agency product number
EMEA/H/C/002377
Active substance
colestilan
International non-proprietary name (INN) or common name
colestilan
Therapeutic area (MeSH)
Hyperphosphatemia
Anatomical therapeutic chemical (ATC) code
V03AE
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Mitsubishi Pharma Europe Ltd
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
21/01/2013
Contact address
Dashwood House
69 Old Broad Street
London EC2M 1QS
United Kingdom

Product information

26/03/2015 BindRen - EMEA/H/C/002377 - IAIN/0004

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.

Pharmacotherapeutic group

Drugs for treatment of hyperkalaemia and hyperphosphataemia

Therapeutic indication

Treatment of hyperphosphataemia in adult patients with chronic kidney disease stage 5 receiving haemodialysis or peritoneal dialysis.

Assessment history

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