Keytruda: Withdrawal of the application to change the marketing authorisation
pembrolizumab
Table of contents
Overview
On 11 October 2017, Merck Sharp & Dohme officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Keytruda in non-small cell lung cancer (NSCLC) to include metastatic non-squamous NSCLC in combination with chemotherapy.
Key facts
Name |
Keytruda |
Product number |
EMEA/H/C/003820 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
17/07/2015 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
11/10/2017 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
-
List item
Withdrawal assessment report for Keytruda (PDF/5.52 MB)
Adopted
First published: 28/11/2017
Last updated: 28/11/2017
EMA/687095/2017 -
List item
Withdrawal letter : Keytruda (PDF/57.46 KB)
First published: 10/11/2017
Last updated: 10/11/2017 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Keytruda (pembrolizumab) (PDF/81.12 KB)
First published: 10/11/2017
Last updated: 10/11/2017
EMA/727539/2017 -
Related information on withdrawals
This text will be replaced by the description of taxonomy term "Template for related information on withdrawals" from vocabulary "String replacement".
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