Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: BindRen   
Auth. number : EU/1/12/804
INN : 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: V03AE - Drugs for treatment of hyperkalemia and hyperphosphatemia
(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