Pharmaceuticals - Community Register

  

List of referrals for human medicinal products

Extraneal

Product name: Extraneal
INN: icodextrin
Indication: Extraneal is recommended as a once daily replacement for a single glucose exchange as part of a continuous ambulatory peritoneal dialysis (CAPD) or automated peritoneal dialysis (APD) regimen for the treatment of chronic renal failure, particularly for patients who have lost ultrafiltration on glucose solutions, because it can extend time on CAPD therapy in such patients.
Marketing Authorisation Holder: Not applicable

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
22/01/2010 Referral EMEA/H/A-6(12)/1203 (2010)415 of 20/01/2010