BindRen
Withdrawn
This medicine's authorisation has been withdrawn
colestilan
MedicineHumanWithdrawn
- 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Assessment Report (EPAR) for BindRen is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
IAIN/0004
26/03/2015
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.
News on BindRen
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