Opdivo: Withdrawal of the application to change the marketing authorisation
nivolumab
Table of contents
Overview
On 27 June 2018, Bristol-Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new use of Opdivo for the treatment of stomach 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 |
27/06/2018 |
Company making the application | |
Withdrawal type |
Post-authorisation |
All documents
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List item
Withdrawal assessment report for Opdivo (PDF/8.27 MB)
First published: 11/12/2018
EMA/CHMP/634022/2018 -
List item
Withdrawal letter: Opdivo (II/0039) (PDF/94 KB)
First published: 27/07/2018
Last updated: 27/07/2018 -
List item
Questions and answers on the withdrawal of the marketing authorisation application for Opdivo (nivolumab) (II/0039) (PDF/79.09 KB)
First published: 27/07/2018
Last updated: 27/07/2018
EMA/504630/2018
Related information on withdrawals
The question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the application at the time of the withdrawal, 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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').
News
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21/07/2023
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26/05/2023
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 24 - 26 April 202326/04/2023
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25/02/2022
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17/09/2021
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25/06/2021
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21/05/2021
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23/04/2021
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26/02/2021
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 October 202016/10/2020
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18/09/2020
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28/02/2020
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16/11/2018
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21/09/2018
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27/07/2018
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27/07/2018
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29/06/2018
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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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15/09/2017
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21/04/2017
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24/03/2017
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 October 201614/10/2016
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01/04/2016
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26/02/2016
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26/02/2016
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25/09/2015
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24/04/2015
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24/04/2015