Xegafri:

Withdrawal of the marketing authorisation application

rociletinib

Overview

On 3 May 2016, Clovis Oncology UK Ltd officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Xegafri, for the treatment of non-small cell lung cancer.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Xegafri (rociletinib) (PDF/67.46 KB)


    First published: 27/05/2016
    Last updated: 27/05/2016
    EMA/352428/2016

  • Key facts

    Name
    Xegafri
    Product number
    EMEA/H/C/004053
    International non-proprietary name (INN) or common name
    • rociletinib
    Active substance
    • rociletinib, hydrobromide
    Date of withdrawal
    05/05/2016
    Company making the application
    Clovis Oncology UK Ltd
    Withdrawal type
    Initial authorisation

    All documents

    Related content

    Related information on withdrawals

    A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter (withdrawal letter Doc. type, leave the 'Author' in properties blank).

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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