Opdivo: Withdrawal of the application to change the marketing authorisation

nivolumab

Overview

On 13 December 2017, Bristol-Myers Squibb Pharma EEIG officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Opdivo to treat colorectal 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
  • nivolumab
Active substance
  • nivolumab
Date of withdrawal
13/12/2017
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An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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