Sutent: Withdrawal of the application to change the marketing authorisation



On 26 June 2018, Pfizer Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application to extend use of Sutent to the treatment of patients at high risk of kidney cancer returning after surgery.

  • List item

    Questions and answers on the withdrawal of application for a change to the marketing authorisation for Sutent (sunitinib) (PDF/82.14 KB)

    First published: 27/07/2018
    Last updated: 27/07/2018

  • Key facts

    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • sunitinib
    Active substance
    • sunitinib
    Date of withdrawal
    Company making the application
    Pfizer Limited
    Withdrawal type

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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