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Assessment Report (EPAR) for BindRen is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Therapeutic Indication
N/A
Therapeutic Area (MeSH)
ATC Code
V03AE
ATC Item
N/A
Pharmacotherapeutic Group
N/A
Active Substance (Summary)
INN / Common Names
EMA Name
BindRen
Medicine Name
BindRen
Aliases
N/ANo risk management plan link.