Yervoy: Withdrawal of the application to change the marketing authorisation

ipilimumab

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
    Yervoy
    Product number
    EMEA/H/C/002213
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    12/07/2011
    International non-proprietary name (INN) or common name
    • ipilimumab
    Active substance
    • Ipilimumab
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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