Zafiride: Withdrawal of the marketing authorisation application
Table of contents
Overview
On 1 June 2017, MolMed S.p.A. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Zafiride for the treatment of advanced malignant pleural mesothelioma.
Key facts
Name |
Zafiride |
Product number |
EMEA/H/C/004455 |
Date of withdrawal |
01/06/2017 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Zafiride (PDF/1.66 MB)
Adopted
First published: 08/02/2018
Last updated: 08/02/2018
EMA/353057/2017 -
List item
Withdrawal letter: Zafiride (PDF/202.18 KB)
First published: 23/06/2017
Last updated: 23/06/2017 -
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Questions and answers on the withdrawal of the marketing authorisation application for Zafiride (NGR-human tumour necrosis factor alpha) (PDF/74.17 KB)
First published: 23/06/2017
Last updated: 23/06/2017
EMA/393395/2017 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').