Teysuno: Withdrawal of the application to change the marketing authorisation

tegafur / gimeracil / oteracil

Overview

On 6 January 2015, Nordic Group BV officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the indication for Teysuno. The change concerned extending the use of Teysuno to treat advanced gastric cancer in combination with platinum-based cancer medicines other than cisplatin.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Teysuno (tegafur/gimeracil/oteracil) (PDF/239.86 KB)


    First published: 23/01/2015
    Last updated: 23/01/2015
    EMA/37171/2015

  • Key facts

    Name
    Teysuno
    Product number
    EMEA/H/C/001242
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    14/03/2011
    International non-proprietary name (INN) or common name
    • tegafur / gimeracil / oteracil
    Active substance
    • tegafur
    • gimeracil
    • oteracil
    Date of withdrawal
    06/01/2015
    Company making the application
    Nordic Group BV
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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