Prohippur: Withdrawal of the marketing authorisation application


On 3 April 2018, Lucane Pharma officially notified the Committee for Medicinal Products for Human Use (CHMP) that it wished to withdraw its application for a marketing authorisation for Prohippur, for the treatment of non-ketotic hyperglycinaemia and urea cycle disorders.

  • List item

    Questions and answers on the withdrawal of the marketing authorisation for Prohippur (sodium benzoate) (PDF/126.13 KB)


    First published: 27/04/2018
    Last updated: 27/04/2018

  • Key facts

    Product number
    Active substance
    • Sodium benzoate
    Date of withdrawal
    Company making the application
    Lucane Pharma
    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    An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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