Faldaprevir Boehringer Ingelheim: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 10 June 2014, Boehringer Ingelheim International GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Faldaprevir Boehringer Ingelheim, for the treatment of hepatitis C.
Key facts
Name |
Faldaprevir Boehringer Ingelheim |
Product number |
EMEA/H/C/003720 |
Active substance |
|
Date of withdrawal |
10/06/2014 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Faldaprevir Boehringer Ingelheim (PDF/2.55 MB)
Adopted
First published: 16/09/2014
Last updated: 16/09/2014
EMA/519229/2014 -
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Withdrawal letter: Faldaprevir Boehringer Ingelheim (PDF/36.58 KB)
First published: 27/06/2014
Last updated: 27/06/2014 -
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Questions and answers on the withdrawal of the marketing authorisation application for Faldaprevir Boehringer Ingelheim (faldaprevir) (PDF/89.5 KB)
First published: 27/06/2014
Last updated: 27/06/2014
EMA/354906/2014 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').