Kepnetic: Withdrawal of the marketing authorisation application

aceneuramic acid

Overview

On 10 November 2016, Ultragenyx UK Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Kepnetic, for the treatment of GNE myopathy.

Key facts

Name
Kepnetic
Product number
EMEA/H/C/004176
International non-proprietary name (INN) or common name
  • aceneuramic acid
Active substance
  • aceneuramic acid
Date of withdrawal
10/11/2016
Company making the application
Ultragenyx UK Limited
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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

How useful was this page?

Add your rating