Repaglinide Sun: Withdrawal of the marketing authorisation application

repaglinide

Overview

On 23 March 2010, Sun Pharmaceutical Industries Europe B.V. officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Repaglinide Sun for the treatment of type 2 diabetes.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation application for Repaglinide Sun (repaglinide) (PDF/51.48 KB)


    First published: 28/04/2010
    Last updated: 28/04/2010
    EMA/211132/2010

  • Key facts

    Name
    Repaglinide Sun
    Product number
    EMEA/H/C/001145
    International non-proprietary name (INN) or common name
    • repaglinide
    Active substance
    • repaglinide
    Date of withdrawal
    25/03/2010
    Company making the application
    Sun Pharmaceutical Industries 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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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