Xiidra: Withdrawal of the marketing authorisation application
Table of contents
Overview
Novartis Europharm Ltd withdrew its application for a marketing authorisation of Xiidra for the treatment of dry eye disease.
The company withdrew the application on 18 June 2020.
Key facts
Name |
Xiidra |
Product number |
EMEA/H/C/004653 |
Active substance |
|
Date of withdrawal |
18/06/2020 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Xiidra (PDF/3.88 MB)
First published: 19/08/2020
EMA/334174/2020 -
List item
Withdrawal letter: Xiidra (PDF/64.13 KB)
First published: 26/06/2020 -
List item
Questions and answers on the withdrawal of application for the marketing authorisation of Xiidra (PDF/128.51 KB)
First published: 26/06/2020
Last updated: 14/07/2020
EMA/334810/2020 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').