Canakinumab Novartis: Withdrawal of the marketing authorisation application
canakinumab
Table of contents
Overview
On 4 December 2018, Novartis Europharm Ltd. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for canakinumab Novartis, for the prevention of serious events such as stroke, heart attack or death in patients who have had a heart attack.
Key facts
Name |
Canakinumab Novartis |
Product number |
EMEA/H/C/004754 |
International non-proprietary name (INN) or common name |
|
Active substance |
|
Date of withdrawal |
04/12/2018 |
Company making the application | |
Withdrawal type |
Initial authorisation |
All documents
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List item
Withdrawal assessment report for Canakinumab Novartis (PDF/3.51 MB)
Adopted
First published: 07/05/2019
EMA/241276/2019 -
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Questions and answers on the withdrawal of the marketing authorisation application for Canakinumab Novartis (canakinumab) (PDF/68.41 KB)
First published: 14/12/2018
EMA/865778/2018 -
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Withdrawal letter: Canakinumab Novartis (PDF/25.13 KB)
First published: 14/12/2018
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').