Opsiria: Withdrawal of the marketing authorisation application
sirolimus
Table of contents
Overview
On 20 May 2016, Santen Oy officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Opsiria, for the treatment of non-infectious uveitis.
Key facts
Name |
Opsiria |
Product number |
EMEA/H/C/003978 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
20/05/2016 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Opsiria (PDF/3.63 MB)
Adopted
First published: 30/09/2016
Last updated: 30/09/2016
EMA/433651/2016 -
List item
Withdrawal letter: Opsiria (PDF/78.95 KB)
First published: 27/05/2016
Last updated: 27/05/2016 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Opsiria (sirolimus) (PDF/92.98 KB)
First published: 27/05/2016
Last updated: 27/05/2016
EMA/358774/2016 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').