Ekesivy:

Withdrawal of the marketing authorisation application

diclofenamide

Overview

Sun Pharmaceutical Industries Europe B.V. withdrew its application for a marketing authorisation of Ekesivy for the treatment of muscle disorders called periodic paralysis.

The company withdrew the application on 2 October 2019.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Ekesivy (diclofenamide) (PDF/76.26 KB)


    First published: 18/10/2019
    EMA/560142/2019

  • Key facts

    Name
    Ekesivy
    Product number
    EMEA/H/C/005141
    International non-proprietary name (INN) or common name
    • diclofenamide
    Active substance
    • Diclofenamide
    Date of withdrawal
    02/10/2019
    Company making the application
    Sun Pharmaceutical Industries Europe 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.

    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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