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


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

  • Key facts

    Ibuprofen/Diphenhydramine Hydrochloride Wyeth
    Product number
    Active substance
    • Ibuprofen
    Date of withdrawal
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

    How useful was this page?

    Add your rating