BindRen

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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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for BindRen has been withdrawn at the request of the marketing authorisation holder.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

Product information documents contain:

  • summary of product characteristics (annex I);
  • manufacturing authorisation holder responsible for batch release (annex IIA);
  • conditions of the marketing authorisation (annex IIB);
  • labelling (annex IIIA);
  • package leaflet (annex IIIB).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Not yet assigned

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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