BindRen

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Withdrawn

This medicine's authorisation has been withdrawn

colestilan
MedicineHumanWithdrawn

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 26 March 2015, the European Commission withdrew the marketing authorisation for BindRen (colestilan) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Mitsubishi Tanabe Pharma Europe Ltd, which notified the European Commission of its decision to permanently discontinue the marketing of the product in the EU for commercial reasons. 

BindRen was granted marketing authorisation in the EU on 21 January 2013 for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis. The marketing authorisation was initially valid for a 5-year period. 

The European Public Assessment Report (EPAR) for BindRen is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

BindRen : EPAR - Summary for the public

Reference Number: EMA/649096/2012

English (EN) (541.48 KB - PDF)

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български (BG) (622.19 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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español (ES) (541.57 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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čeština (CS) (603.24 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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dansk (DA) (560.1 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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Deutsch (DE) (562.92 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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eesti (ET) (539.24 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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ελληνικά (EL) (650.64 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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français (FR) (565.42 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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italiano (IT) (540.75 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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latviešu (LV) (602.51 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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lietuvių (LT) (564.62 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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magyar (HU) (599.75 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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Malti (MT) (609.45 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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Nederlands (NL) (538.37 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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polski (PL) (625.17 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

português (PT) (539.56 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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română (RO) (563.82 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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slovenčina (SK) (604.46 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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slovenščina (SL) (618.8 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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suomi (FI) (540.67 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
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svenska (SV) (539.51 KB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

Product information

BindRen : EPAR - Product Information

English (EN) (1.2 MB - PDF)

Prima publicare: Cea mai recent:
Vizualizare

български (BG) (2.56 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

español (ES) (1.17 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

čeština (CS) (1.88 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

dansk (DA) (1.19 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

Deutsch (DE) (1.19 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

eesti (ET) (1.16 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

ελληνικά (EL) (2.43 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

français (FR) (1.22 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

hrvatski (HR) (1.3 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

italiano (IT) (1.18 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

latviešu (LV) (1.96 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

lietuvių (LT) (1.3 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

magyar (HU) (1.98 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

Malti (MT) (2.07 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

Nederlands (NL) (1.19 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

polski (PL) (2 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

português (PT) (1.18 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

română (RO) (1.35 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

slovenčina (SK) (2.04 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

slovenščina (SL) (1.93 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

suomi (FI) (1.19 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

svenska (SV) (1.16 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

Íslenska (IS) (1.18 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare

norsk (NO) (1.18 MB - PDF)

Prima publicare: 21/02/2013 Cea mai recent: 01/04/2015
Vizualizare
Latest procedure affecting product information:IAIN/0004
26/03/2015
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

Product details

Name of medicine
BindRen
Active substance
colestilan
International non-proprietary name (INN) or common name
colestilan
Therapeutic area (MeSH)
Hyperphosphatemia
Anatomical therapeutic chemical (ATC) code
V03AE

Therapeutic indication

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

Authorisation details

EMA product number
EMEA/H/C/002377
Marketing authorisation holder
Mitsubishi Pharma Europe Ltd

Dashwood House
69 Old Broad Street
London EC2M 1QS
United Kingdom

Marketing authorisation issued
21/01/2013
Withdrawal of marketing authorisation
26/05/2015
Revision
2

Assessment history

BindRen : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (552.95 KB - PDF)

Prima publicare: Cea mai recent:
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BindRen : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/169525/2012

English (EN) (3.18 MB - PDF)

Prima publicare: Cea mai recent:
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CHMP summary of positive opinion for BindRen

Reference Number: EMA/555461/2012

English (EN) (512.52 KB - PDF)

Prima publicare: Cea mai recent:
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