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List of refusals for human medicinal products
Winfuran
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 |
European Commission procedures |
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 |