Vekacia: Withdrawal of the marketing authorisation application
ciclosporin
Table of contents
Overview
On 14 November 2008, Novagali Pharma S.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Vekacia, for the treatment of vernal keratoconjunctivitis. Vekacia was designated as an orphan medicinal product on 6 April 2006.
Key facts
Name |
Vekacia |
Product number |
EMEA/H/C/000904 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
14/11/2008 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
-
List item
Withdrawal assessment report for Vekacia (PDF/134.17 KB)
Adopted
First published: 26/02/2009
Last updated: 26/02/2009
EMEA/CHMP/51709/2009 -
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Novagali Pharma S.A. withdraws its marketing authorisation application for Vekacia (ciclosporin) (PDF/23.81 KB)
First published: 17/11/2008
Last updated: 17/11/2008
EMEA/610677/2008 -
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Withdrawal letter : Vekacia (PDF/19.14 KB)
First published: 14/11/2008
Last updated: 14/11/2008 -
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Questions and answers on the withdrawal of the marketing application for Vekacia (PDF/39.72 KB)
First published: 02/12/2008
Last updated: 02/12/2008
EMEA/611497/2008 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').