Canakinumab Novartis: Withdrawal of the marketing authorisation application

canakinumab

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
  • canakinumab
Active substance
  • Canakinumab
Date of withdrawal
04/12/2018
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 (withdrawal letter Doc. type, leave the 'Author' in properties blank).

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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