Keytruda: Withdrawal of the application to change the marketing authorisation

pembrolizumab

Overview

On 11 October 2017, Merck Sharp & Dohme officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend the use of Keytruda in non-small cell lung cancer (NSCLC) to include metastatic non-squamous NSCLC in combination with chemotherapy.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Keytruda (pembrolizumab) (PDF/81.12 KB)


    First published: 10/11/2017
    Last updated: 10/11/2017
    EMA/727539/2017

  • Key facts

    Name
    Keytruda
    Product number
    EMEA/H/C/003820
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    16/07/2015
    International non-proprietary name (INN) or common name
    • pembrolizumab
    Active substance
    • Pembrolizumab
    Date of withdrawal
    11/10/2017
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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