Tygacil: Withdrawal of the application to change the marketing authorisation



On 22 April 2008, Wyeth Europa Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a new indication for Tygacil, in the treatment of community-acquired pneumonia.

  • List item

    Questions and answers on the withdrawal of the application for a change to the marketing authorisation for Tygacil (PDF/32.71 KB)

    First published: 30/05/2008
    Last updated: 30/05/2008

  • Key facts

    Product number
    Date of issue of market authorisation valid throughout the European Union (if applicable)
    International non-proprietary name (INN) or common name
    • tigecycline
    Active substance
    • Tigecycline
    Date of withdrawal
    Company making the application
    Pfizer Europe MA EEIG
    Withdrawal type

    All documents

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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 90').

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