Winfuran: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 17 January 2014, Toray International U.K. Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Winfuran, intended for the treatment of severe uraemic pruritus (a form of itching) in patients with end-stage kidney disease on dialysis.
Key facts
Name |
Winfuran |
Product number |
EMEA/H/C/002683 |
Date of withdrawal |
17/01/2014 |
Company making the application | |
Withdrawal type |
Initial authorisation |
Related information on withdrawals
A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.
An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').