Plivensia: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 26 October 2017, Janssen-Cilag International NV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Plivensia, for the treatment of rheumatoid arthritis.
Key facts
Name |
Plivensia |
Product number |
EMEA/H/C/004165 |
Active substance |
|
Date of withdrawal |
26/10/2017 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Plivensia (PDF/6.75 MB)
First published: 05/02/2018
Last updated: 05/02/2018
EMA/CHMP/576037/2017 -
List item
Withdrawal letter: Plivensia (PDF/91.51 KB)
First published: 10/11/2017
Last updated: 10/11/2017 -
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Questions and answers on the withdrawal of the marketing authorisation application for Plivensia (sirukumab) (PDF/75.07 KB)
First published: 10/11/2017
Last updated: 05/02/2018
EMA/727596/2017 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').