Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


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Product information

Invented name: BindRen
Auth. number : EU/1/12/804
Active substance : colestilan
ATC: Anatomical main group: V - Various
Therapeutic subgroup: V03 - All other therapeutic products
Pharmacological subgroup: V03A - All other therapeutic products
Chemical subgroup: V03AE - Drugs for treatment of hyperkalemia and hyperphosphatemia
Chemical substance: V03AE06 - Colestilan
(See WHO ATC Index)
Indication: BindRen is indicated for the treatment of hyperphosphataemia in adult patients with Chronic Kidney Disease (CKD) Stage 5 receiving haemodialysis or peritoneal dialysis
Marketing Authorisation Holder: Mitsubishi Tanabe Pharma Europe Ltd.
Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
23/01/2013 Centralised - Authorisation EMEA/H/C/2377 (2013)359 of 21/01/2013
23/10/2013 Centralised - Variation EMEA/H/C/2377/IAin/2
Updated with Decision(2014)8185 of 27/10/2014
10/07/2014 Centralised - Variation EMEA/H/C/2377/IA/4
Updated with Decision(2014)8185 of 27/10/2014
29/10/2014 Centralised - Yearly update (2014)8185 of 27/10/2014
09/03/2015 Centralised - Withdrawal (2015)1571 of 05/03/2015
30/03/2015 Rectificative Decision (2015)2246 of 26/03/2015