Ibuprofen/Diphenhydramine Hydrochloride Wyeth: Withdrawal of the marketing authorisation application

Overview

On 7 January 2010, Wyeth Consumer Healthcare officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth, for use in the treatment of mild to moderate pain in adults who are having difficulty sleeping because of the pain.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation for Ibuprofen/Diphenhydramine Hydrochloride Wyeth (PDF/65.62 KB)


    First published: 28/01/2010
    Last updated: 28/01/2010
    EMA/23377/2010

  • Key facts

    Name
    Ibuprofen/Diphenhydramine Hydrochloride Wyeth
    Product number
    EMEA/H/C/001108
    Active substance
    • Ibuprofen
    Date of withdrawal
    07/01/2010
    Company making the application
    Wyeth Consumer Healthcare
    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.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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