Restaysis: Withdrawal of the marketing authorisation application
ciclosporin
Table of contents
Overview
On 25 April 2018, Allergan Pharmaceuticals International Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Restaysis, for the treatment of moderate dry eye disease.
Key facts
Name |
Restaysis |
Product number |
EMEA/H/C/004229 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
25/04/2018 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Restaysis (PDF/1.5 MB)
Adopted
First published: 06/08/2018
Last updated: 06/08/2018
EMA/293638/2018 -
List item
Withdrawal letter: Restaysis (PDF/546.7 KB)
First published: 01/06/2018
Last updated: 01/06/2018 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Restaysis (ciclosporin) (PDF/73.18 KB)
First published: 01/06/2018
Last updated: 01/06/2018
EMA/275525/2018 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').