Duloxetine Sandoz: Withdrawal of the marketing authorisation application

duloxetine

Overview

On 08 April 2015, Sandoz GmbH officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Duloxetine Sandoz, for the treatment of depression, diabetic nerve pain and generalised anxiety disorder.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Duloxetine Sandoz (duloxetine) (PDF/72.43 KB)


    First published: 24/04/2015
    Last updated: 24/04/2015
    EMA/249807/2015

  • Key facts

    Name
    Duloxetine Sandoz
    Product number
    EMEA/H/C/004009
    International non-proprietary name (INN) or common name
    • duloxetine
    Active substance
    • duloxetine
    Date of withdrawal
    08/04/2015
    Company making the application
    Sandoz GmbH
    Withdrawal type
    Initial authorisation

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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