Opdivo: Withdrawal of the application to change the marketing authorisation

nivolumab

Overview

Bristol-Myers Squibb Pharma EEIG withdrew its application for the use of Opdivo and Yervoy in the treatment of metastatic non-small cell lung cancer that has not been treated previously.

The company withdrew the application on 30 January 2020.

  • List item

    Withdrawal of application to change the marketing authorisation for Opdivo (nivolumab) and Yervoy (ipilimumab) (PDF/140.66 KB)

    Adopted

    First published: 28/02/2020
    EMA/92336/2020

  • 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
    30/01/2020
    Company making the application
    Bristol-Myers Squibb Pharma EEIG
    Withdrawal type
    Post-authorisation

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

    News

    How useful was this page?

    Add your rating