Prohippur: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 3 April 2018, Lucane Pharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Prohippur, for the treatment of non-ketotic hyperglycinaemia and urea cycle disorders.
Key facts
Name |
Prohippur |
Product number |
EMEA/H/C/004150 |
Active substance |
|
Date of withdrawal |
03/04/2018 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Prohippur : EPAR - Withdrawal assessment Report (PDF/2.85 MB)
Adopted
First published: 05/07/2018
Last updated: 05/07/2018
EMA/358079/2018 -
List item
Withdrawal letter: Prohippur (PDF/18.71 KB)
First published: 27/04/2018
Last updated: 27/04/2018 -
List item
Questions and answers on the withdrawal of the marketing authorisation for Prohippur (sodium benzoate) (PDF/126.13 KB)
Adopted
First published: 27/04/2018
Last updated: 27/04/2018
EMA/258015/2018 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').