Docetaxel Mylan: Withdrawal of the marketing authorisation application
docetaxel
Table of contents
Overview
On 8 March 2010, Mylan S.A.S. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Docetaxel Mylan intended to be used to treat breast cancer, non-small-cell lung cancer, prostate cancer, gastric adenocarcinoma, and head and neck cancer.
Key facts
Name |
Docetaxel Mylan |
Product number |
EMEA/H/C/001193 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
08/03/2010 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Docetaxel Mylan (PDF/180.17 KB)
Adopted
First published: 18/06/2010
Last updated: 18/06/2010
EMA/383877/2010 -
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Withdrawal letter : Docetaxel Mylan (PDF/26.47 KB)
First published: 26/03/2010
Last updated: 26/03/2010 -
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Mylan S.A.S. withdraws its marketing authorisation application for Docetaxel Mylan (docetaxel) (PDF/48.51 KB)
First published: 15/03/2010
Last updated: 15/03/2010
EMA/164498/2010 -
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Questions and answers on the withdrawal of the marketing authorisation application for Docetaxel Mylan (docetaxel) (PDF/51.32 KB)
First published: 26/03/2010
Last updated: 26/03/2010
EMA/166011/2010 -
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').