Lumevoq: Withdrawal of the marketing authorisation application
lenadogene nolparvovec
Table of contents
Overview
Gensight Biologics SA withdrew its application for a marketing authorisation of Lumevoq for treating loss of vision due to an eye condition known as Leber hereditary optic neuropathy.
The company withdrew the application on 20 April 2023.
Key facts
Name |
Lumevoq |
Product number |
EMEA/H/C/005047 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
20/04/2023 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Lumevoq (PDF/3.61 MB)
Adopted
First published: 08/08/2023
EMA/CHMP/248970/2023 -
List item
Withdrawal letter: Lumevoq (PDF/86.89 KB)
First published: 26/04/2023 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Lumevoq (lenadogene nolparvovec) (PDF/136.98 KB)
First published: 26/04/2023
EMA/186712/2023 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').