Erbitux: Withdrawal of the application to change the marketing authorisation
cetuximab
Table of contents
Overview
On 17 September 2012, Merck KGaA officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Erbitux, to extend its use in the treatment of non-small-cell lung cancer.
Key facts
Name |
Erbitux |
Product number |
EMEA/H/C/000558 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
29/06/2004 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
17/09/2012 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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Withdrawal assessment report for Erbitux (PDF/1.6 MB)
Adopted
First published: 22/11/2012
Last updated: 22/11/2012
EMA/CHMP/628005/2012 -
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Withdrawal letter: Erbitux (cetuximab) (PDF/285.31 KB)
First published: 12/10/2012
Last updated: 12/10/2012 -
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Merck KGaA withdraws its application for an extension of the indication for Erbitux (cetuximab) (PDF/54.2 KB)
First published: 19/09/2012
Last updated: 19/09/2012
EMA/607000/2012 -
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Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Erbitux (cetuximab) (PDF/50.95 KB)
First published: 12/10/2012
Last updated: 12/10/2012
EMA/608075/2012 -
Related information on withdrawals
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