Intrinsa: Withdrawal of the application to change the marketing authorisation

testosterone

Overview

On 22 September 2010, Warner Chilcott Pharmaceuticals UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a change to the marketing authorisation for Intrinsa, to extend treatment to all postmenopausal women with hypoactive sexual desire disorder.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Intrinsa (testosterone) (PDF/51.76 KB)


    First published: 26/10/2010
    Last updated: 26/10/2010
    EMA/632261/2010

  • Key facts

    Name
    Intrinsa
    Product number
    EMEA/H/C/000634
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    28/07/2006
    International non-proprietary name (INN) or common name
    • testosterone
    Active substance
    • Testosterone
    Date of withdrawal
    29/09/2010
    Company making the application
    Warner Chilcott UK Ltd.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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