Elmisol: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 29 May 2017, ACE Pharmaceuticals BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Elmisol, for the treatment of nephrotic syndrome.
Key facts
Name |
Elmisol |
Product number |
EMEA/H/C/004330 |
Date of withdrawal |
29/05/2017 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Elmisol (PDF/1.74 MB)
Adopted
First published: 18/07/2017
Last updated: 18/07/2017
EMA/CHMP/824474/2016 -
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Withdrawal letter: Elmisol (PDF/1.52 MB)
First published: 23/06/2017
Last updated: 23/06/2017 -
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Questions and answers on the withdrawal of the marketing authorisation application for Elmisol (levamisole) (PDF/74.96 KB)
First published: 23/06/2017
Last updated: 23/06/2017
EMA/CHMP/380586/2017 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').