Opdivo: Withdrawal of the application to change the marketing authorisation

nivolumab

Overview

On 20 July 2017, 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 in the treatment of liver cancer.

Key facts

Name
Opdivo
Product number
EMEA/H/C/003985
Date of issue of market authorisation valid throughout the European Union (if applicable)
18/06/2015
International non-proprietary name (INN) or common name
  • nivolumab
Active substance
  • nivolumab
Date of withdrawal
20/07/2017
Company making the application
Bristol-Myers Squibb Pharma EEIG
Withdrawal type
Post-authorisation

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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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