Pioglitazone Teva Generics: Withdrawal of the marketing authorisation application

pioglitazone

Overview

On 26 January 2012, Teva Generics B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wishes to withdraw its application for a marketing authorisation for Pioglitazone Teva Generics, for the treatment of type-2 diabetes.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Pioglitazone Teva Generics (PDF/54.08 KB)


    First published: 30/04/2012
    Last updated: 30/04/2012
    EMA/282199/2012

  • Key facts

    Name
    Pioglitazone Teva Generics
    Product number
    EMEA/H/C/002448
    International non-proprietary name (INN) or common name
    • pioglitazone
    Active substance
    • pioglitazone hydrochloride
    Date of withdrawal
    26/01/2012
    Company making the application
    Teva Pharma B.V.
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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