Pharmaceuticals - Community Register


List of refusals for human medicinal products


Product name: Winfuran
Active substance: nalfurafine
Indication: Treatment of severe uraemic pruritus (UP) in patients of 18 years of age or older, with end stage renal disease (ESRD) undergoing regular dialysis.
Marketing Authorisation Holder: Toray International U.K. Limited

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Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/03/2014 Centralised - Refusal of marketing authorisation EMEA/H/C/2683 (2014)2066 of 21/03/2014