Keytruda: Withdrawal of the application to change the marketing authorisation

pembrolizumab

Overview

Merck Sharp & Dohme B.V. withdrew its application for the use of Keytruda in the treatment of cancer of the oesophagus (food pipe).

The company withdrew its application on 10 December 2019.

  • List item

    Questions and answers on the withdrawal of application to change the marketing authorisation for Keytruda (pembrolizumab) (PDF/132.72 KB)


    First published: 31/01/2020
    Last updated: 19/03/2020
    EMA/673300/2019

  • Key facts

    Name
    Keytruda
    Product number
    EMEA/H/C/003820
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    17/07/2015
    International non-proprietary name (INN) or common name
    • pembrolizumab
    Active substance
    • Pembrolizumab
    Date of withdrawal
    10/12/2019
    Company making the application
    Merck Sharp & Dohme B.V.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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