Effentora: Withdrawal of the application to change the marketing authorisation

fentanyl

Overview

On 11 July 2013, Teva Pharma B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Effentora, to extend the treatment for breakthrough pain to adult patients with chronic (long-term) persistent pain from causes other than cancer.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Effentora (fentanyl) (PDF/71.75 KB)


    First published: 26/07/2013
    Last updated: 26/07/2013
    EMA/447220/2013

  • Key facts

    Name
    Effentora
    Product number
    EMEA/H/C/000833
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    04/04/2008
    International non-proprietary name (INN) or common name
    • fentanyl
    Active substance
    • fentanyl
    Date of withdrawal
    11/07/2013
    Company making the application
    Teva B.V.
    Withdrawal type
    Post-authorisation

    All documents

    Related content

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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