Cokiera: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 3 August 2016, AbbVie Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Cokiera, for the treatment of chronic hepatitis C.
Key facts
Name |
Cokiera |
Product number |
EMEA/H/C/004235 |
Date of withdrawal |
03/08/2016 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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Withdrawal assessment report for Cokiera (PDF/1.23 MB)
Adopted
First published: 24/10/2016
Last updated: 24/10/2016
EMA/606748/2016 -
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Withdrawal letter: Cokiera (PDF/24.05 KB)
First published: 16/09/2016
Last updated: 16/09/2016 -
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Questions and answers on the withdrawal of the marketing authorisation application for Cokiera (dasabuvir / ombitasvir / paritaprevir / ritonavir) (PDF/74.2 KB)
First published: 16/09/2016
Last updated: 16/09/2016
EMA/541043/2016 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').