Xyndari: Withdrawal of the marketing authorisation application
Table of contents
Overview
Emmaus Medical Europe Ltd withdrew its application for a marketing authorisation of Xyndari for the treatment of sickle cell disease.
The company withdrew the application on 18 September 2019.
Key facts
Name |
Xyndari |
Product number |
EMEA/H/C/004734 |
Date of withdrawal |
18/09/2019 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Xyndari (PDF/4.56 MB)
First published: 11/02/2020
EMA/CHMP/257513/2019 -
List item
Withdrawal letter: Xyndari (PDF/263.27 KB)
First published: 18/10/2019 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Xyndari (glutamine) (PDF/113.42 KB)
First published: 18/10/2019
EMA/521995/2019 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 201918/10/2019
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28/06/2019
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29/05/2019