BindRen

colestilan

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The marketing authorisation for BindRen has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
BindRen : EPAR - Summary for the public BG = bălgarski 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public ES = español 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public CS = čeština 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public DA = dansk 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public DE = Deutsch 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public ET = eesti keel 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public EL = elliniká 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public EN = English 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public FR = français 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public IT = italiano 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public LV = latviešu valoda 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public LT = lietuvių kalba 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public HU = magyar 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public MT = Malti 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public NL = Nederlands 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public PL = polski 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public PT = português 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public RO = română 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public SK = slovenčina 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public SL = slovenščina 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public FI = suomi 2013-02-21 2015-04-01
BindRen : EPAR - Summary for the public SV = svenska 2013-02-21 2015-04-01

This EPAR was last updated on 01/04/2015 .

Authorisation details

Product details

Product details for BindRen
NameBindRen
Agency product numberEMEA/H/C/002377
Active substance

colestilan

International non-proprietary name (INN) or common name

colestilan

Therapeutic area Hyperphosphatemia
Anatomical therapeutic chemical (ATC) code V03AE
Additional monitoring

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

Publication details

Publication details for BindRen
Marketing-authorisation holder

Mitsubishi Pharma Europe Ltd

Revision2
Date of issue of marketing authorisation valid throughout the European Union21/01/2013

Contact address:

Mitsubishi Pharma Europe Ltd
Dashwood House
69 Old Broad Street
London EC2M 1QS
United Kingdom

Product information

Product information

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

Name Language First published Last updated
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - Product Information SV = svenska 2013-02-21 2015-04-01

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
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01
BindRen : EPAR - All Authorised presentations SV = svenska 2013-02-21 2015-04-01

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

Changes since initial authorisation of medicine

Name Language First published Last updated
BindRen : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 2014-01-03 2015-04-01

Initial marketing-authorisation documents

Name Language First published Last updated
BindRen : EPAR - Public assessment report SV = svenska 2013-02-21 2015-04-01
CHMP summary of positive opinion for BindRen SV = svenska 2012-10-01 2015-04-01

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on BindRen