Balimek: Withdrawal of the marketing authorisation application
binimetinib
Table of contents
Overview
On 4 January 2018, Pierre Fabre Médicament officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Balimek, for the treatment of melanoma.
Key facts
Name |
Balimek |
Product number |
EMEA/H/C/004052 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
04/01/2018 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for: Balimek (binimetinib) (PDF/2.85 MB)
First published: 27/03/2018
Last updated: 27/03/2018
EMA/CHMP/86716/2018 -
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Withdrawal letter: Balimek (PDF/173.94 KB)
First published: 26/01/2018
Last updated: 26/01/2018 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Balimek (binimetinib) (PDF/73.87 KB)
First published: 26/01/2018
Last updated: 27/03/2018
EMA/41972/2018 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').