Pemetrexed ditromethamine Hospira: Withdrawal of the marketing authorisation application

pemetrexed

Overview

On 22 September 2016, Hospira UK Limited officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pemetrexed (as ditromethamine) Hospira, for the treatment of malignant pleural mesothelioma and non-small-cell lung cancer.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Pemetrexed ditromethamine Hospira (PDF/74.88 KB)


    First published: 14/10/2016
    Last updated: 14/10/2016
    EMA/659373/2016

  • Key facts

    Name
    Pemetrexed ditromethamine Hospira
    Product number
    EMEA/H/C/004306
    International non-proprietary name (INN) or common name
    • pemetrexed
    Active substance
    • pemetrexed ditromethamine
    Date of withdrawal
    22/09/2016
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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