Dexamethasone Taw: Withdrawal of the marketing authorisation application

dexamethasone phosphate


Taw Pharma (Ireland) Ltd withdrew its application for a marketing authorisation of Dexamethasone Taw for the treatment of several inflammatory and other conditions.

The company withdrew the application on 20 January 2021 because it was unable to remove preservatives from the medicine within the timeframe required by EMA.

  • List item

    Questions and answers on the withdrawal of application for the marketing authorisation of Dexamethasone Taw (dexamethasone phosphate) (PDF/139.71 KB)

    First published: 29/01/2021

  • Key facts

    Dexamethasone Taw
    Product number
    International non-proprietary name (INN) or common name
    • dexamethasone phosphate
    Active substance
    • Dexamethasone (sodium phosphate)
    Date of withdrawal
    Company making the application
    Taw Pharma (Ireland) Ltd
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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