Canakinumab Novartis: Withdrawal of the marketing authorisation application



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

Canakinumab Novartis
Product number
International non-proprietary name (INN) or common name
  • canakinumab
Active substance
  • Canakinumab
Date of withdrawal
Company making the application
Novartis Europharm Limited
Withdrawal type
Initial authorisation

All documents

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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