Opdivo: Withdrawal of the application to change the marketing authorisation
nivolumab
Table of contents
Overview
On 13 December 2017, Bristol-Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Opdivo to treat colorectal cancer.
Key facts
Name |
Opdivo |
Product number |
EMEA/H/C/003985 |
Date of issue of market authorisation valid throughout the European Union (if applicable) |
19/06/2015 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
13/12/2017 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal assessment report for Opdivo (II-30) (PDF/6.84 MB)
Adopted
First published: 13/02/2018
Last updated: 13/02/2018
EMA/12767/2018 -
List item
Withdrawal letter: Opdivo (PDF/123.11 KB)
First published: 26/01/2018
Last updated: 26/01/2018 -
List item
Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Opdivo (nivolumab) (PDF/87.48 KB)
First published: 26/01/2018
Last updated: 26/01/2018
EMA/51006/2018
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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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 201826/01/2018
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